Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- K252845Venus Nova (FP-2001)2Cleared 510(K)
- K252740Voyant® Open Fusion Device (EB240/Open Fusion)2Cleared 510(K)
- K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)2Cleared 510(K)
- K250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch2Cleared 510(K)
- K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)2Cleared 510(K)
- K250852Coolfase2Cleared 510(K)
- K252367InbellaMulti System2Cleared 510(K)
- K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)2Cleared 510(K)
- K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)2Cleared 510(K)
- K251899E Blator2Cleared 510(K)
- K251334NEW DOUBLO 2.02Cleared 510(K)
- K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)2Cleared 510(K)
- K252576Legend X Platform2Cleared 510(K)
- K250483PhotonBlade 3; PhotonBlade 3 Smoke Evacuation2Cleared 510(K)
- K250217AGNES Ultra2Cleared 510(K)
- K251108Erbe ESU Model VIO® 3n with Accessories2Cleared 510(K)
- K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)2Cleared 510(K)
- K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)2Cleared 510(K)
- K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)2Cleared 510(K)
- K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)2Cleared 510(K)
- K251327XERF2Cleared 510(K)
- K252215InbellaMAX System2Cleared 510(K)
- K250065DENSITY; DENZA; DENSITY Noir2Cleared 510(K)
- K243120HybridAPC probe2Cleared 510(K)
- K251235Electrosurgical Pads2Cleared 510(K)
- K242996EndyMed PRO MAX2Cleared 510(K)
- K242907DELPHI System2Cleared 510(K)
- K250657gi2000 Electrosurgical Generator2Cleared 510(K)
- K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)2Cleared 510(K)
- K250048NEUROMARK System (NMK00301)2Cleared 510(K)
- K243176BLESSING System2Cleared 510(K)
- K240857Youmagic FLM System (YM5-U1)2Cleared 510(K)
- K250400Vigeon Laparoscopic Universal Smoke Evacuator (VG003)2Cleared 510(K)
- K242469RFMagik Lite2Cleared 510(K)
- K250327OptaBlate Radiofrequency (RF) Generator System2Cleared 510(K)
- K242773Electro Lube NXT2Cleared 510(K)
- K243451FiAPC plus probes2Cleared 510(K)
- K242241Sunny2Cleared 510(K)
- K243918Vasoview Hemopro 3 Power Supply2Cleared 510(K)
- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)2Cleared 510(K)
- K250200InbellaBody System2Cleared 510(K)
- K242983CROMA Electrosurgical Generator (PRD-EMR-050)2Cleared 510(K)
- K250068Venclose digiRF Generator (VCRFG1)2Cleared 510(K)
- K243139Reverso Pro System2Cleared 510(K)
- K240311JETT Medical II2Cleared 510(K)
- K243929Oligio X2Cleared 510(K)
- K243067The ETHICON™ Total Energy System2Cleared 510(K)
- K243737Inbella RF System2Cleared 510(K)
- K233118DUET-V (Model: ESK-3261DV)2Cleared 510(K)
- K243097RM STAR EX with RMS Needle2Cleared 510(K)
- K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)2Cleared 510(K)
- K242688Finiff System2Cleared 510(K)
- K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))2Cleared 510(K)
- K240758Radiofrequency Generator System, Cura RF Electrode2Cleared 510(K)
- K242630Aerin Console2Cleared 510(K)
- K231216POTENZA2Cleared 510(K)
- K240897Cellinew2Cleared 510(K)
- K241157Secret MAX Multi-platform RF System2Cleared 510(K)
- K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator2Cleared 510(K)
- K242286Superflow Prime Treatment System (ASP-1M)2Cleared 510(K)
- K241099Plasonic (Plasonic)2Cleared 510(K)
- K231287POTENZA2Cleared 510(K)
- K243217Legend X Desktop System2Cleared 510(K)
- K242266PhotonBlade 3; PhotonBlade 3 Smoke Evacuation2Cleared 510(K)
- K242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)2Cleared 510(K)
- K241535Vybe RF II2Cleared 510(K)
- K242044FiAPC plus probes2Cleared 510(K)
- K241635da Vinci E-200 Electrosurgical Generator2Cleared 510(K)
- K240932HybridTherm System2Cleared 510(K)
- K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)2Cleared 510(K)
- K241621Da Vinci Monopolar and Bipolar Adapters (378896)2Cleared 510(K)
- K240780InMode RF System2Cleared 510(K)
- K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)2Cleared 510(K)
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)2Cleared 510(K)
- K241022Sterile single use tip cleaner (WK800-S10 , WK800-S20)2Cleared 510(K)
- K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6)2Cleared 510(K)
- K240070Profound Matrix2Cleared 510(K)
- K233123SILKRO2Cleared 510(K)
- K240017InMode System with the Morpheus8 90 Applicator2Cleared 510(K)
- K240657ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-2Cleared 510(K)
- K241055Electro Lube NXT2Cleared 510(K)
- K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter2Cleared 510(K)
- K233120CWM-930S, FIXER DV92Cleared 510(K)
- K233099Gladiator2Cleared 510(K)
- K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)2Cleared 510(K)
- K240999Legend X Applicator VO2Cleared 510(K)
- K240964FLOW 90? Wand2Cleared 510(K)
- K240248Volnewmer™2Cleared 510(K)
- K232805Kronos Electrocautery Device2Cleared 510(K)
- K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)2Cleared 510(K)
- K233849BTL-4992Cleared 510(K)
- K222958mJOULE RF System and Accessories2Cleared 510(K)
- K233604BTL-785S2Cleared 510(K)
- K233642InMode RF System2Cleared 510(K)
- K233002BEED 2,5, BEED 3,82Cleared 510(K)
- K232301Define RF Microneedling System2Cleared 510(K)
- K233705CellFX Percutaneous Electrode System (SYS3000)2Cleared 510(K)
- K232703Disposable Bipolar Forceps2Cleared 510(K)
- K230837PlazMagik2Cleared 510(K)
- K233830OsteoCool™ 2.0 RF Ablation System2Cleared 510(K)
- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)2Cleared 510(K)
- K240313Oligio X2Cleared 510(K)
- K231985Disposable Grounding Pad2Cleared 510(K)
- K232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G2Cleared 510(K)
- K234140VIVA combo RF System (VIVA combo RF System)2Cleared 510(K)
- K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)2Cleared 510(K)
- K231405Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode2Cleared 510(K)
- K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 12Cleared 510(K)
- K23299210THERMA2Cleared 510(K)
- K233374Secret Pro2Cleared 510(K)
- K232947SIRA™ RFA Electrosurgical Device2Cleared 510(K)
- K232290INTELLIO SHIFT System2Cleared 510(K)
- K231615Disposable Endoscopic Bipolar2Cleared 510(K)
- K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes2Cleared 510(K)
- K232033HYBRIDknife® flex2Cleared 510(K)
- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)2Cleared 510(K)
- K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force2Cleared 510(K)
- K233346Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);2Cleared 510(K)
- K231012CoolSeal Trinity2Cleared 510(K)
- K233147PiXel8-RF2Cleared 510(K)
- K231327POWERSEAL Sealer and Divider2Cleared 510(K)
- K222997VVR Generator system2Cleared 510(K)
- K233185MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System2Cleared 510(K)
- K232223PlaDuo System2Cleared 510(K)
- K231732CleanSeal Advanced Bipolar Vessel Sealer Maryland2Cleared 510(K)
- K231749Radio Frequency System2Cleared 510(K)
- K232903Legend X Platform2Cleared 510(K)
- K231495The Evolve System with the Transform Applicator2Cleared 510(K)
- K232809Cross Vascular RF Generator and Footswitch (optional accessory)2Cleared 510(K)
- K230650Monopolar Electrode Surgical Instrument2Cleared 510(K)
- K232460Disposable electrosurgical pencil (MD1000)2Cleared 510(K)
- K232407Cautery Protective Actuation System (CPAS)2Cleared 510(K)
- K232763Electrode Handpieces (VCT, RFTV, BMDT series)2Cleared 510(K)
- K230467BTL-899F2Cleared 510(K)
- K231146AliTight2Cleared 510(K)
- K221743Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes2Cleared 510(K)
- K223303Spinery™ RF Ablation System2Cleared 510(K)
- K231872Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)2Cleared 510(K)
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)2Cleared 510(K)
- K230663Density2Cleared 510(K)
- K223856NuEra Tight RF Family2Cleared 510(K)
- K231126Eblator Device2Cleared 510(K)
- K231790The InMode System with the Morpheus8 Applicators2Cleared 510(K)
- K230968VYBE RF Electrosurgical System2Cleared 510(K)
- K223135AblatePal Radiofrequency Ablation System2Cleared 510(K)
- K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)2Cleared 510(K)
- K231212da Vinci E-200 Electrosurgical Generator2Cleared 510(K)
- K223033Tixel® 2 System2Cleared 510(K)
- K230586Renuvion® Micro Handpiece2Cleared 510(K)
- K230498ArtiSential Laparoscopic Instruments-Electrodes2Cleared 510(K)
- K222556BTL-785X2Cleared 510(K)
- K230593Victan2Cleared 510(K)
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- K183594Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J2Cleared 510(K)
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- K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X2Cleared 510(K)
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- K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length2Cleared 510(K)
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- K180200ESG-300, APU-300, Pressure Reducer, MAPC Probes2Cleared 510(K)
- K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S2Cleared 510(K)
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- K173877BOWA Neutral Electrodes2Cleared 510(K)
- K172624Voyant 5mm Fusion Device2Cleared 510(K)
- K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument2Cleared 510(K)
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- K173112LAP-iX2Cleared 510(K)
- K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length2Cleared 510(K)
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- K170054iSurg2Cleared 510(K)
- K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)2Cleared 510(K)
- K171262TempSure2Cleared 510(K)
- K170758Thermage FLX System and Accessories2Cleared 510(K)
- K171359Pollogen Legend+ System2Cleared 510(K)
- K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini2Cleared 510(K)
- K172367Stryker Integrated Bipolar Cord and Tubing Sets2Cleared 510(K)
- K171523Monopolar Single Use Laparoscopic Instrument2Cleared 510(K)
- K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A2Cleared 510(K)
- K171684Epix Electrosurgical Probe with Smoke Evacuation2Cleared 510(K)
- K171717AUTOCON III 4002Cleared 510(K)
- K170325SECRET RF2Cleared 510(K)
- K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider2Cleared 510(K)
- K170908PK AIM2Cleared 510(K)
- K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator2Cleared 510(K)
- K171094Thermi Reusable Non-invasive RF Electrode2Cleared 510(K)
- K163615Snowden-Pencer MicroLap 3mm Laparoscopic Instruments2Cleared 510(K)
- K170107Surgi Max Ultra2Cleared 510(K)
- K170777Bovie J-Plasma Precise FLEX Handpiece2Cleared 510(K)
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated2Cleared 510(K)
- K170721Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil2Cleared 510(K)
- K170358joimax Endovapor 22Cleared 510(K)
- K163415SlimShape System2Cleared 510(K)
- K170582Saf-T-Vac Smoke and Fluid Evacuator2Cleared 510(K)
- K170610PlasmaBlade T2Cleared 510(K)
- K170377TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM2Cleared 510(K)
- K170161New Deantronics E Green™ Electrosurgical Monopolar Pencils2Cleared 510(K)
- K170296CoreCath 2.7S2Cleared 510(K)
- K170116Thermi Injectable RF Electrodes2Cleared 510(K)
- K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator2Cleared 510(K)
- K163450VIVA combo RF System2Cleared 510(K)
- K170105Jac-Cell Medic testers2Cleared 510(K)
- K170170Valleylab FT10 Electrosurgical Platform2Cleared 510(K)
- K163548ENSEAL X1 Large Jaw Tissue Sealer2Cleared 510(K)
- K161949OsteoCool V-3 RF Ablation System2Cleared 510(K)
- K162034OBS Electrosurgical Generator (Model: OBS-350A)2Cleared 510(K)
- K162802Barrx Anorectal RFA Wand2Cleared 510(K)
- K162810InSeca ARC Stylus, Aerin Console2Cleared 510(K)
- K162490Disc-FX System2Cleared 510(K)
- K160469AGNES2Cleared 510(K)
- K162770Relign System2Cleared 510(K)
- K161307NICO Myriad2Cleared 510(K)
- K163373PK AIM2Cleared 510(K)
- K163190InMode RF System2Cleared 510(K)
- K163106CODMAN Integrated Bipolar Cord and Tubing Set2Cleared 510(K)
- K162676Voyant Open Fusion Device2Cleared 510(K)
- K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coated2Cleared 510(K)
- K162656ESU-1 Electrosurgical Generator2Cleared 510(K)
- K161378joimax Electrosurgical Instruments2Cleared 510(K)
- K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps2Cleared 510(K)
- K161481Ambient HipVac 50 Wand with Integrated Finger Switches2Cleared 510(K)
- K160706ReNew V Handpiece Laparoscopic Instruments2Cleared 510(K)
- K160103Spetzler Malis Dual Illuminating Bipolar Forceps2Cleared 510(K)
- K161038PK Morcellator2Cleared 510(K)
- K162547Viveve System2Cleared 510(K)
- K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)2Cleared 510(K)
- K161825PK AIM2Cleared 510(K)
- K161994Aerin Medical Stylus2Cleared 510(K)
- K161804LigaSure Retractable L-Hook Laparoscopic Sealer/Divider2Cleared 510(K)
- K162053PhotonBlade2Cleared 510(K)
- K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated2Cleared 510(K)
- K161581Arthrex Synergy RF System2Cleared 510(K)
- K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)2Cleared 510(K)
- K160554Enseal X1 Large Jaw Tissue Sealer2Cleared 510(K)
- K162074Werewolf RF20000 Controller, FLOW 50 Wand2Cleared 510(K)
- K161661Thermi RF Accessories2Cleared 510(K)
- K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp2Cleared 510(K)
- K162075NICO TRIOwand2Cleared 510(K)
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating2Cleared 510(K)
- K153727INTRAcel Premium Fractional RF Micro Needle (FRM) System2Cleared 510(K)
- K152731XP1100 RF2Cleared 510(K)
- K153055ACE Electrosurgical Resection and Vaporization Electrodes Series2Cleared 510(K)
- K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device2Cleared 510(K)
- K161305Habib EUS RFA2Cleared 510(K)
- K153017Voyant Fine Fusion2Cleared 510(K)
- K160602JustRight Surgical Vessel Sealing System2Cleared 510(K)
- K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator2Cleared 510(K)
- K160539BiZact Open Sealer/Divider2Cleared 510(K)
- K151229ABC D-FLEX PROBE2Cleared 510(K)
- K153288Voyant Open Fusion Device2Cleared 510(K)
- K160290Valleylab REM Polyhesive Infant Patient Return Electrode2Cleared 510(K)
- K160053Monopolar single-use HF cable2Cleared 510(K)
- K150364ERBE ESU Model VIO dV with Accessories2Cleared 510(K)
- K160639Electrosurgical Generator ESG-2002Cleared 510(K)
- K160050SERFAS 90-S Electrosurgical Probe2Cleared 510(K)
- K160128Endopath Electrosurgery Probe Plus II2Cleared 510(K)
- K160206VirtuoSaph Plus Endoscopic Vessel Harvesting System2Cleared 510(K)
- K152059Disposable General Electrode2Cleared 510(K)
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System2Cleared 510(K)
- K160693Neptune E-SEP Smoke Evacuation Pencil2Cleared 510(K)
- K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM2Cleared 510(K)
- K160360Barrx FLEX RFA Energy Generator2Cleared 510(K)
- K160160Non-Telescopic PenEvac2Cleared 510(K)
- K152933Vesalius2Cleared 510(K)
- K150915SPINAUT-P2Cleared 510(K)
- K160041Cobbra RF Tissue Dissector2Cleared 510(K)
- K151743THUNDERBEAT Open Fine Jaw2Cleared 510(K)
- K151793InMode RF System2Cleared 510(K)
- K151480Epix Electrosurgical Probe with Smoke Evacuation2Cleared 510(K)
- K152702ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)2Cleared 510(K)
- K153679Stryker Neptune E-SEP Smoke Evacuation Pencil2Cleared 510(K)
- K153675Paragon T2 Wand with Integrated Cable2Cleared 510(K)
- K152777Bovie Disposable Bipolar Ablator2Cleared 510(K)
- K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated2Cleared 510(K)
- K151273InMode FRF Applicator2Cleared 510(K)
- K152860HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL2Cleared 510(K)
- K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension2Cleared 510(K)
- K152219PK AIM2Cleared 510(K)
- K152057OsteoCool V-3 RF Ablation System2Cleared 510(K)
- K150637Aerin Medical Wand Model FG0112Cleared 510(K)
- K152570Bovie J-Plasma Precise 360 Handpiece2Cleared 510(K)
- K142410Elliquence Electrodes2Cleared 510(K)
- K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe2Cleared 510(K)
- K143235RF20000a Controller, FLOW 50 Wand2Cleared 510(K)
- K150835LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip2Cleared 510(K)
- K151044CLICKLINE Scissor Insert for Single Use2Cleared 510(K)
- K134036WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT2Cleared 510(K)
- K152317Stretta Catheter2Cleared 510(K)
- K152031New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.2Cleared 510(K)
- K151649Valleylab FT10 Electrosurgical Platform2Cleared 510(K)
- K150959Sutter Bipolar Forceps-Calvian2Cleared 510(K)
- K150112HS AMICA DEVICES FAMILY2Cleared 510(K)
- K152286LigaSure Curved, Small Jaw, Open Sealer/Divider2Cleared 510(K)
- K151325Bovie J-Plasma Handpiece2Cleared 510(K)
- K150735Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot2Cleared 510(K)
- K150251Barrx Anorectal RFA Wand2Cleared 510(K)
- K151858Caiman Seal and Cut Technology2Cleared 510(K)
- K151696Caiman Seal and Cut Technology2Cleared 510(K)
- K143103PROPENCIL Smoke Pencil2Cleared 510(K)
- K150029Habib EUS RFA2Cleared 510(K)
- K142480OsteoCool V-2 RF Ablation System2Cleared 510(K)
- K143559XP1000 RF2Cleared 510(K)
- K150824TD-Wand2Cleared 510(K)
- K151222Cautery Tip Cleaner2Cleared 510(K)
- K150297PlasmaBlade UPPP and Suction Coagulator2Cleared 510(K)
- K150161Venus Viva SR Device2Cleared 510(K)
- K150993NICO TRIOwand2Cleared 510(K)
- K143536Voyant Fine Fusion Device2Cleared 510(K)
- K142208Monopolar Laparascopic Accessories2Cleared 510(K)
- K143654Valleylab LS10 Generator2Cleared 510(K)
- K143475VAPR Tripolar Suction Electrode2Cleared 510(K)
- K143517Voyant Open Sealer-Divider Device2Cleared 510(K)
- K143662Bissinger Monopolar Forceps and Cables2Cleared 510(K)
- K143109XP3002Cleared 510(K)
- K141790AQANIFE2Cleared 510(K)
- K150024Bissinger Monopolar Cables2Cleared 510(K)
- K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope2Cleared 510(K)
- K141587E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER2Cleared 510(K)
- K142929Ligasure Blunt Tip Sealer/Divider2Cleared 510(K)
- K142759PK Cutting Forceps for ESG-400 Workstation2Cleared 510(K)
- K142350PK J-HOOK2Cleared 510(K)
- K142229Laparoscopic FMsealer2Cleared 510(K)
- K143175AEx Generator; PlasmaBlade T2Cleared 510(K)
- K142289PK Spatula2Cleared 510(K)
- K143161Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)2Cleared 510(K)
- K142910Legacy BX2Cleared 510(K)
- K142154PK NEEDLE2Cleared 510(K)
- K142975Bovie Ultimate High Frequency Electrosurgical Generator2Cleared 510(K)
- K140624HICURA HAND INSTRUMENTS2Cleared 510(K)
- K141507TWO SKIN TREATMENT SYSTEM2Cleared 510(K)
- K143145SafeAir Smoke Pencil2Cleared 510(K)
- K140926INMODE WMFACE DEVICE2Cleared 510(K)
- K1428685mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin2Cleared 510(K)
- K134006DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable2Cleared 510(K)
- K140008VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM2Cleared 510(K)
- K132771KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K142757LiNA PowerBlade Plus HC2Cleared 510(K)
- K141904VIORA V-TOUCH2Cleared 510(K)
- K142538LiNA SafeAir Smoke Pencil2Cleared 510(K)
- K142364Barrx RFA Self Sizing Balloon Catheter2Cleared 510(K)
- K141122HARMONIC SCALLOP BLADE, GENERATOR G112Cleared 510(K)
- K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE2Cleared 510(K)
- K141357BARRX FLEX RFA ENERGY GENERATOR2Cleared 510(K)
- K141153LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED2Cleared 510(K)
- K141225ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD2Cleared 510(K)
- K141858CLOSURERFG RADIOFREQUENCY GENERATOR2Cleared 510(K)
- K140896VAPR ARCTIC SUCTION ELECTRODE2Cleared 510(K)
- K140603ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM2Cleared 510(K)
- K141484OPEN FMSEALER2Cleared 510(K)
- K132797L'DISQ2Cleared 510(K)
- K140500SKINTACT2Cleared 510(K)
- K140578ARTHROSCOPIC ENERGY SYSTEM2Cleared 510(K)
- K140459ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM2Cleared 510(K)
- K140658THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES2Cleared 510(K)
- K140629VENUS SWAN(MP)22Cleared 510(K)
- K140006ENDOSHIELD BURN PROTECTION SYSTEM2Cleared 510(K)
- K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH2Cleared 510(K)
- K140422HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM2Cleared 510(K)
- K140384FMWAND HANDPIECE SE2Cleared 510(K)
- K133405MINNIE2Cleared 510(K)
- K132703THUNDERBEAT2Cleared 510(K)
- K140255STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)2Cleared 510(K)
- K140839CAIMAN SEAL AND CUT TECHNOLOGY2Cleared 510(K)
- K140495LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE2Cleared 510(K)
- K134054BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K133273LIGER MEDICAL ESU-1102Cleared 510(K)
- K131696VESALIUS2Cleared 510(K)
- K133726MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE2Cleared 510(K)
- K132300EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE2Cleared 510(K)
- K133167MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD2Cleared 510(K)
- K133338LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)2Cleared 510(K)
- K132837LINA POWERBLADE PLUS2Cleared 510(K)
- K131758SURGEN U2Cleared 510(K)
- K132754NEOGEN PSR SYSTEM2Cleared 510(K)
- K133180ERBE ESU MODEL VIO DV WITH ACCESSORIES2Cleared 510(K)
- K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS2Cleared 510(K)
- K132974AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR2Cleared 510(K)
- K132743HARVESTING CANNULA2Cleared 510(K)
- K130689SYMPHONY RF GENERATOR2Cleared 510(K)
- K131058BIPOLAR FORCEPS2Cleared 510(K)
- K122949MEDLINE SUCTION COAGULATOR2Cleared 510(K)
- K132224UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES2Cleared 510(K)
- K130110MEDDUSA BIPOLAR SYSTEM2Cleared 510(K)
- K133017ESTECH COBRA(R) GENESIS BIPOLAR CLAMP2Cleared 510(K)
- K132199DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST2Cleared 510(K)
- K131435ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,2Cleared 510(K)
- K130983GENII ARC SMART ARGON PROBE2Cleared 510(K)
- K132665PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC2Cleared 510(K)
- K130760ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K132431THERMAGE CPT SYSTEM2Cleared 510(K)
- K132136SINGLE USE GROUNDING PAD2Cleared 510(K)
- K132374BAYLIS MEDICAL RF PERFORATION PROBE V2.02Cleared 510(K)
- K131949AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES2Cleared 510(K)
- K131012SUTTER BIPOLAR FORCEPS - SUPERGLISS2Cleared 510(K)
- K132099ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND2Cleared 510(K)
- K130027DISPOSABLE NEUTRAL ELECTRODE GP2022Cleared 510(K)
- K130793NEWA SKIN THERAPY SYSTEM2Cleared 510(K)
- K123061ACE MONOPOLAR ATTACHMENT2Cleared 510(K)
- K131205ARTHROCARE HEAD AND NECK COBLATION WAND2Cleared 510(K)
- K120510TRANSCEND2Cleared 510(K)
- K123366SURGITRON 4.0 DUAL RF S5-IEC2Cleared 510(K)
- K122652ARTHROCARE TURBINATOR WAND2Cleared 510(K)
- K121481INFINI RADIOFREQUENCY SYSTEM2Cleared 510(K)
- K123662THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM2Cleared 510(K)
- K123478STINGRAY BIPOLAR FORCEPS2Cleared 510(K)
- K122200A3F FRATIONAL2Cleared 510(K)
- K122716PLASMATRODE SALINE SAFE TUR ELECTRODE2Cleared 510(K)
- K122966XP2002Cleared 510(K)
- K130744LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER2Cleared 510(K)
- K123429OLYMPUS ENERGY POWER SYSTEM (EPS)2Cleared 510(K)
- K123353CIQ CONTROLLER, CIQ WANDS2Cleared 510(K)
- K124029MICROLINE FLEXIBLE LIGATING SHEARS2Cleared 510(K)
- K130596CAIMAN SEAL AND CUT TECHNOLOGY2Cleared 510(K)
- K123444LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER2Cleared 510(K)
- K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW2Cleared 510(K)
- K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)2Cleared 510(K)
- K123201AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER2Cleared 510(K)
- K122383EM3 AEM MONITOR AEM CONNECTORS2Cleared 510(K)
- K123260DETACHATIP III2Cleared 510(K)
- K123172KOGENT BIPOLAR FORCEPS2Cleared 510(K)
- K120791AMBIENT TURBOFLASH 90 IFS2Cleared 510(K)
- K120454SAFEAIR SMOKE PENCIL,2Cleared 510(K)
- K121977PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM2Cleared 510(K)
- K121085HET BIPOLAR LIGATOR SYSTEM2Cleared 510(K)
- K113380PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR2Cleared 510(K)
- K122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES2Cleared 510(K)
- K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR2Cleared 510(K)
- K122425VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT2Cleared 510(K)
- K120909EC 2.7 ENDOSCOPIC CUTTER2Cleared 510(K)
- K123141ENSEAL TRIO TISSUE SEALING DEVICE2Cleared 510(K)
- K122092MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM2Cleared 510(K)
- K120116SERF ABLATION SYSTEM SERF ABLATION NEEDLE2Cleared 510(K)
- K121150ALMA LASERS FAMILY OF PIXEL RF TIPS2Cleared 510(K)
- K113407SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS2Cleared 510(K)
- K113572LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER2Cleared 510(K)
- K122086THERMAL LIGATING SHEARS2Cleared 510(K)
- K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS2Cleared 510(K)
- K120581SC TIP CLEANER2Cleared 510(K)
- K121290AQUAMANTRYS3 BSC 9.1S2Cleared 510(K)
- K120527ALPHA ORTHOPAEDICS AT2 SYSTEM2Cleared 510(K)
- K120476MACROLYTE DISPERSIVE ELECTRODE2Cleared 510(K)
- K120322CONMED SUREFIT DUAL DISPERSIVE ELECTRODE2Cleared 510(K)
- K113597MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES2Cleared 510(K)
- K111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP2Cleared 510(K)
- K120537AQUAMANTYS3 9.5 XL BIPOLAR SEALER2Cleared 510(K)
- K120431HALO90 ULTRA ABLATION CATHETER2Cleared 510(K)
- K120095SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND2Cleared 510(K)
- K120416INSULATION TESTER2Cleared 510(K)
- K113265GENII GI 4000 ELECTROSUGICAL GENERATOR2Cleared 510(K)
- K113090LEVEEN SUPERSLIM NEEDLE ELECTRODE2Cleared 510(K)
- K111523OSTEOCOOL (TM) RF ABLATION SYSTEM2Cleared 510(K)
- K111670VENUS FREEZE (MP)2 SYSTEM2Cleared 510(K)
- K113545VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN2Cleared 510(K)
- K112233BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE2Cleared 510(K)
- K111986LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM2Cleared 510(K)
- K111202SURGICAL TISSUE MANAGEMENT SYSTEM2Cleared 510(K)
- K112454HALO60 ABLATION CATHETER2Cleared 510(K)
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- K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
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- K031082EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK2Cleared 510(K)
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- K031080EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS2Cleared 510(K)
- K031078EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS2Cleared 510(K)
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- K024266MSI TA ELECTRODES2Cleared 510(K)
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- K030473SENORX ES-3002Cleared 510(K)
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- K023924AUTOCON II 200 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K022532TISSUELINK BIPOLAR FLOATING BALL DEVICE2Cleared 510(K)
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- K022856BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K030142THERMACOOL TC SYSTEM2Cleared 510(K)
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- K024047ERBE VIO APC WITH ACCESSORIES2Cleared 510(K)
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- K023601RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 300862Cleared 510(K)
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- K021402THERMAGE THERMACOOL TC SYSTEM2Cleared 510(K)
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- K013873COBRA CARDIAC ELECTROSURGICAL SYSTEM2Cleared 510(K)
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- K021299CONMED HEATWAVE HAND-CONTROLLED ELETRODE2Cleared 510(K)
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- K020711WALLACH LOOP ELECTRODE2Cleared 510(K)
- K021364MODIFICATION TO ENTEC PLASMA WANDS2Cleared 510(K)
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- K020579AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR032Cleared 510(K)
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- K020408SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF2Cleared 510(K)
- K012279PATTON TRIPOL2Cleared 510(K)
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- K021077MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD2Cleared 510(K)
- K021046COBRA COOLED SURGICAL PROBE, MODEL 1596X2Cleared 510(K)
- K020186CONMED SYSTEM 5000 ESU2Cleared 510(K)
- K020135CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-61202Cleared 510(K)
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- K020047RUBICOR BREAST BIOPSY DEVICE2Cleared 510(K)
- K020067GYRUS ENT SOMNOPLASTY GENERATOR2Cleared 510(K)
- K013369RESECTION ABLATOR2Cleared 510(K)
- K020622ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS2Cleared 510(K)
- K014290ENTEC PLASMA WANDS2Cleared 510(K)
- K020031EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-3022Cleared 510(K)
- K014260TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE2Cleared 510(K)
- K014251NTERO HOTROD SYSTEM2Cleared 510(K)
- K020557ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS2Cleared 510(K)
- K014207REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF0832Cleared 510(K)
- K014216SECCA SYSTEM2Cleared 510(K)
- K014172NELSON ELECTROSURGICAL UNIT, MODEL GN6402Cleared 510(K)
- K013680CARBODISSECTING ENDOSCOPE2Cleared 510(K)
- K014201AARON REUSABLE ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K013904BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-2302Cleared 510(K)
- K013730ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES2Cleared 510(K)
- K013668BERCHTOLD ELEKTROTOM 106 HITT2Cleared 510(K)
- K012314DYONICS ELECTROBLADE RESECTOR2Cleared 510(K)
- K013622NUCLEOTOMY INTRADISCAL CATHETER2Cleared 510(K)
- K013639THERMAGE THERMACOOL TC SYSTEM2Cleared 510(K)
- K013641SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS2Cleared 510(K)
- K014224PRECISION PLUS TUNA OFFICE SYSTEM2Cleared 510(K)
- K014222ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD2Cleared 510(K)
- K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY2Cleared 510(K)
- K013139STELLARTECH COAGULATION SYSTEM2Cleared 510(K)
- K012631REPROCESSED SOFT TISSUE ABLATORS2Cleared 510(K)
- K013463ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND2Cleared 510(K)
- K012725TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES2Cleared 510(K)
- K012679REPROCESSED RF ARTHROSCOPY PROBES2Cleared 510(K)
- K013255SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF2Cleared 510(K)
- K012700VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K012695VANGUARD REPROCESSED ARTHROSCOPIC WANDS2Cleared 510(K)
- K013348MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-1662Cleared 510(K)
- K012519ARTHROCARE ELECTROSURGERY WANDS2Cleared 510(K)
- K012625REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K012315LEVEEN ELECTRODE2Cleared 510(K)
- K013034MODIFICATION TO: THERMACOOL IIA2Cleared 510(K)
- K012986BIPOLAR IRRIGATION FORCEPS2Cleared 510(K)
- K012004EASY GUIDE ELECTROSURGICAL ACCESS DEVICE2Cleared 510(K)
- K012033MULTIFUNCTION ENDOSCOPIC INSTRUMENT2Cleared 510(K)
- K011929HANDPIECE SHEATH-MODEL #A9102Cleared 510(K)
- K012799ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL2Cleared 510(K)
- K012488MODIFICATION TO:ENDIUS BIPOLAR SHEATH2Cleared 510(K)
- K011722ATRICURE BIPOLAR COAGULATION SYSTEM2Cleared 510(K)
- K012129ORTHO DEVELOPMENT ORION-I EMF SYSTEM2Cleared 510(K)
- K011279ENTEC EVAC PLASMA WAND2Cleared 510(K)
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- K010815NTERO NOMAD SYSTEM2Cleared 510(K)
- K003190EN BLOC BIOPSY SYSTEM2Cleared 510(K)
- K001442ESU HANDSWITCHING PENCIL2Cleared 510(K)
- K010710SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES2Cleared 510(K)
- K010465DENSTAT2Cleared 510(K)
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- K010487BIPOLAR PENCIL, MODEL 3901-002, 3900-0022Cleared 510(K)
- K010662MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL2Cleared 510(K)
- K010956COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X2Cleared 510(K)
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- K002000MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS;2Cleared 510(K)
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- K002981ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS1502Cleared 510(K)
- K010192ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION2Cleared 510(K)
- K010112BIPOLAR COAGULATION SYSTEM2Cleared 510(K)
- K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR2Cleared 510(K)
- K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS11002Cleared 510(K)
- K003897ENDIUS BIPOLAR SHEATH2Cleared 510(K)
- K003717INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF2Cleared 510(K)
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- K003773CLEAN SCRAPE2Cleared 510(K)
- K010060RITA STARBURST XLI ELECTROSURGICAL DEVICE2Cleared 510(K)
- K003462ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-0452Cleared 510(K)
- K002269ELECTROSURGICAL PROBES AND DEVICES-GELTX2Cleared 510(K)
- K003050CRYOSURGICAL UNIT AND ACCESSORIES2Cleared 510(K)
- K001955AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A12502Cleared 510(K)
- K003624REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V57022Cleared 510(K)
- K003092MODIFICATION TO VNUS CLOSURE SYSTEM2Cleared 510(K)
- K003249PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 12282Cleared 510(K)
- K003674NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP2Cleared 510(K)
- K003183THERMAGE THERMACOOL II SYSTEM2Cleared 510(K)
- K003005TISSUELINK BIPOLAR FORCEPS2Cleared 510(K)
- K002841COOL-TEC ELECTRODES2Cleared 510(K)
- K003587CLEARGLIDE PRECISION BIPOLAR DEVICE2Cleared 510(K)
- K002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE2Cleared 510(K)
- K003471MAGNA TEK ESU-4002Cleared 510(K)
- K002752BAYONET FORCEPS BIPOLAR IRRIGATING2Cleared 510(K)
- K002680TISSUELINK MONOPOLAR FLOATING BALL'2Cleared 510(K)
- K002582PILLING E-FRAZIER BIPOLAR SUCTION TUBE2Cleared 510(K)
- K003060PLASMAKINETIC GENERATOR2Cleared 510(K)
- K002257TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-1002Cleared 510(K)
- K002898CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST2Cleared 510(K)
- K001986SURGITRON IEC II2Cleared 510(K)
- K002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM2Cleared 510(K)
- K002021HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE2Cleared 510(K)
- K002002SUREFIT DISPERSIVE ELECTRODE2Cleared 510(K)
- K001407SURGITRON IEC II2Cleared 510(K)
- K001936ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD2Cleared 510(K)
- K001723COOL-TEC ELECTRODES2Cleared 510(K)
- K000944THERMAGE THERMACOOL SYSTEM2Cleared 510(K)
- K001904ARTHROCARE FLOW CONTROL UNIT2Cleared 510(K)
- K001150ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE2Cleared 510(K)
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- K001151ELECTROSURGICAL ELECTRODE FAMILY2Cleared 510(K)
- K001593MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL2Cleared 510(K)
- K001273STARION INSTRUMENTS POWER POINT CAUTERY CLAMP2Cleared 510(K)
- K001262THERMAL CAUTERY FORCEPS2Cleared 510(K)
- K001159HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL2Cleared 510(K)
- K001161ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),2Cleared 510(K)
- K001330SOVEREIGN BIPOLAR INSTRUMENTS2Cleared 510(K)
- K001302ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C2Cleared 510(K)
- K000720SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE2Cleared 510(K)
- K993991HM-930 ELECTROSURGICAL UNIT2Cleared 510(K)
- K001253SURGITRON IEC II2Cleared 510(K)
- K001029GEIGER NEEDLE ADAPTER, MODEL 4062Cleared 510(K)
- K001438SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K000778ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-012Cleared 510(K)
- K000348COLORADO MICRODISSECTION NEEDLE2Cleared 510(K)
- K000480ACTIVE ELECTRODE MONITORING SYSTEM2Cleared 510(K)
- K000496EVERSHEARS BIPOLAR SCISSORS2Cleared 510(K)
- K000961AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE2Cleared 510(K)
- K000936VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM2Cleared 510(K)
- K000245CSM STRETTA SYSTEM2Cleared 510(K)
- K000911MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-900572Cleared 510(K)
- K000241RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR2Cleared 510(K)
- K982556LEVEEN NEEDLE ELECTRODE2Cleared 510(K)
- K993412BITX PROBES2Cleared 510(K)
- K000032LEVEEN NEEDLE ELECTRODE2Cleared 510(K)
- K994319MODULAP2Cleared 510(K)
- K992180VISAGE COSMETIC SURGERY, MODEL V50002Cleared 510(K)
- K000501ELECTROSURGICAL GENERATOR, MODEL S12Cleared 510(K)
- K000511MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS2Cleared 510(K)
- K994365DYONICS ELECTROBLADE2Cleared 510(K)
- K000296STARION CAUTERY HOOK2Cleared 510(K)
- K000250CAUTERY FORCEPS WITH FOOTSWITCH2Cleared 510(K)
- K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE2Cleared 510(K)
- K000228ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND2Cleared 510(K)
- K000170SECCA TUBULAR ELECTRODE DEVICE, MODEL A40002Cleared 510(K)
- K994336BITX PROBES2Cleared 510(K)
- K000074ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS2Cleared 510(K)
- K000036ENTEC REFLEX WAND 55, MODEL E4055-002Cleared 510(K)
- K992805ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)2Cleared 510(K)
- K000044ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS2Cleared 510(K)
- K992045ELECTROSURGICAL ELECTRODE FAMILY2Cleared 510(K)
- K994173STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-2302Cleared 510(K)
- K994333ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES2Cleared 510(K)
- K994075GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 4352Cleared 510(K)
- K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS2Cleared 510(K)
- K993967ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 9200022Cleared 510(K)
- K993112XOMED ENT RF SYSTEM2Cleared 510(K)
- K992581ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS2Cleared 510(K)
- K993854ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES2Cleared 510(K)
- K993944RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE2Cleared 510(K)
- K992996ENABLE ENDOSCOPIC BIPOLAR SCISSORS2Cleared 510(K)
- K992931NON-STICK BIPOLAR FORCEPS2Cleared 510(K)
- K993647UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F2Cleared 510(K)
- K992542TUBULAR ELECTRODE DEVICE2Cleared 510(K)
- K992760SELECT-SUTTER MICRO BIPOLAR FORCEPS2Cleared 510(K)
- K991140ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES2Cleared 510(K)
- K993265SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 6002Cleared 510(K)
- K992764ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-1032Cleared 510(K)
- K992769ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-2Cleared 510(K)
- K992382SURGITRON RADIOLASE2Cleared 510(K)
- K993055DEXIDE BIPOLAR FORCEPS II** DEVICE2Cleared 510(K)
- K992714MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-900102Cleared 510(K)
- K992460CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY2Cleared 510(K)
- K990723DYONICS VARICOSE VEIN ABLATION BLADE2Cleared 510(K)
- K992972ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H20002Cleared 510(K)
- K992572NTERO RF SLEEVE2Cleared 510(K)
- K990362INSTRUMENT, ULTRASONIC, SCALPEL2Cleared 510(K)
- K991529CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S4002Cleared 510(K)
- K972267HELICA TC2Cleared 510(K)
- K991218ORATEC BIPOLAR ABLATION PROBES2Cleared 510(K)
- K992693RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 902Cleared 510(K)
- K992345CHRISTOUDIAS SLIM TIP ELECTRODE INSERT2Cleared 510(K)
- K992485MONOPOLAR ELECTRODES AND CABLES2Cleared 510(K)
- K992149GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 4052Cleared 510(K)
- K991960SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH2Cleared 510(K)
- K991669PMS 750 FINGERSWITCH2Cleared 510(K)
- K992406VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM2Cleared 510(K)
- K992408ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES2Cleared 510(K)
- K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-46012Cleared 510(K)
- K992186QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT2Cleared 510(K)
- K991291STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION2Cleared 510(K)
- K991859DEXIDE BIPOLAR FORCEPS II ** DEVICE2Cleared 510(K)
- K991814MULTACHOICE INSTRUMENTS2Cleared 510(K)
- K991190DEFLECTABLE ELECTROSURGICAL PROBES2Cleared 510(K)
- K984240ENDOPATH ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K991855CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX2Cleared 510(K)
- K990859DEFLECTABLE TAC ELECTROTHERMAL PROBE2Cleared 510(K)
- K990586CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES2Cleared 510(K)
- K990474ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES2Cleared 510(K)
- K983986CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K990146SURGITRON2Cleared 510(K)
- K982816VNUS CLOSURE SYSTEM2Cleared 510(K)
- K984018HEMOSLEEVE, MODEL 4.0MM, 5.5MM2Cleared 510(K)
- K984552COOL-TIP RF SYSTEM2Cleared 510(K)
- K984352AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR2Cleared 510(K)
- K984417BIPOLAR GRASPING FORCEPS BIQ+2Cleared 510(K)
- K983208WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K984276DISPOSABLE ELECTROSURGERY GROUNDING PAD2Cleared 510(K)
- K984239SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z2Cleared 510(K)
- K984236AARON ESU FOOT-CONTROL ADAPTER #A1205A2Cleared 510(K)
- K984275THE GOLDEN TIP ELECTRO-SURGICAL PROBE2Cleared 510(K)
- K983852BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-4292Cleared 510(K)
- K983782ELECTROSURGICAL DISPERSIVE ELECTRODE2Cleared 510(K)
- K983743BISURE LAPAROSCOPIC BIPOLAR FORCEPS2Cleared 510(K)
- K972335CLEANCUT2Cleared 510(K)
- K983761AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP52Cleared 510(K)
- K984185MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY2Cleared 510(K)
- K983236BIPOLAR HF CABLE2Cleared 510(K)
- K981781ELECTROSURGICAL UNIT2Cleared 510(K)
- K983116ELECTROSURGICAL INFLATABLE BASKET ELECTRODES2Cleared 510(K)
- K982212VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-0102Cleared 510(K)
- K983871RITA MODEL 70 ELECTROSURGICAL PROBE
- K983788AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE2Cleared 510(K)
- K982971ORATEC TAC-C, MONOPOLAR CAUTERY PROBE2Cleared 510(K)
- K982854MR COMPATIBLE LEVEEN NEEDLE ELECTRODE2Cleared 510(K)
- K982826MEGA 20002Cleared 510(K)
- K982748BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 2242Cleared 510(K)
- K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 12002Cleared 510(K)
- K982984ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K981888SMOKE-EVAC2Cleared 510(K)
- K974170DUOSTAR2Cleared 510(K)
- K982176KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR2Cleared 510(K)
- K982884DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH2Cleared 510(K)
- K982742DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH2Cleared 510(K)
- K982749MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-22Cleared 510(K)
- K982746MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-12Cleared 510(K)
- K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH2Cleared 510(K)
- K981570AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD2Cleared 510(K)
- K982744DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH2Cleared 510(K)
- K982705MIDAS TOUCH BIPOLAR FORCEPS2Cleared 510(K)
- K981981ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 192Cleared 510(K)
- K982677UNI/MONOPOLAR HF CABLE2Cleared 510(K)
- K981916LIGASURE VESSEL SEALING SYSTEM2Cleared 510(K)
- K981870VISAGE COSMETIC SURGERY SYSTEM2Cleared 510(K)
- K982130RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 2012Cleared 510(K)
- K981919BISSINGER CABLES, CAT. NO. 801000XX2Cleared 510(K)
- K982309SMOKE EVACUATION ATTACHMENT 130XXX TBD2Cleared 510(K)
- K981908UM-150A2Cleared 510(K)
- K981589ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES2Cleared 510(K)
- K981672RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR2Cleared 510(K)
- K981614NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL2Cleared 510(K)
- K981361POWERSTAR BIPOLAR SCISSORS2Cleared 510(K)
- K981310MAGNATEK C-3002Cleared 510(K)
- K981321BIPOLAR FORCEPS SET (MODULAR)2Cleared 510(K)
- K980177SUGITRON MODEL: IEC2Cleared 510(K)
- K980913CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T52Cleared 510(K)
- K981219OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES2Cleared 510(K)
- K980170SURGITRON2Cleared 510(K)
- K981416MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-152Cleared 510(K)
- K981724O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-1002Cleared 510(K)
- K981430UNION MEDICAL UM-D30 COAGULATOR2Cleared 510(K)
- K981389DISPOSABLE RE-NEW FORCEPS2Cleared 510(K)
- K981188ELECTROSURGICAL CAUTERY PROBES2Cleared 510(K)
- K980393SOPRANO CRYO-THERAPY SYSTEM2Cleared 510(K)
- K981220SYSTEM 7500 ABC ELECTROSURGICAL UNIT2Cleared 510(K)
- K9807583 MM SELEC-TIP LAPAROSCOPIC SCISSORS2Cleared 510(K)
- K974793ELMED ESU 120 M/M DIGITAL2Cleared 510(K)
- K974464ORATEC SPINECATH INTRADISCAL CATHETER2Cleared 510(K)
- K963965CTS MIDCAB STITCHER2Cleared 510(K)
- K980366AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/2402Cleared 510(K)
- K980171DERMASENSE PLUS DISPERSIVE ELECTRODE2Cleared 510(K)
- K973197FIRE STICK2Cleared 510(K)
- K974521VNUS CLOSURE SYSTEM2Cleared 510(K)
- K974250VERSASTAT MULTIPOLAR SCISSORS AND CABLES2Cleared 510(K)
- K974484ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE2Cleared 510(K)
- K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)2Cleared 510(K)
- K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)2Cleared 510(K)
- K973701SOMNUS TISSUE COAGULATING ELECTRODE2Cleared 510(K)
- K971829MIS ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K972358ORATEC MODEL ENDOTAC PROBE2Cleared 510(K)
- K974066RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS2Cleared 510(K)
- K972562BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED2Cleared 510(K)
- K974022VAPR2Cleared 510(K)
- K973478ARTHROCARE SINUS ELECTROSURGERY SYSTEM2Cleared 510(K)
- K970837SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE2Cleared 510(K)
- K970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE2Cleared 510(K)
- K973890UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K973618SOMNOPLASTY SYSTEM2Cleared 510(K)
- K973682BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,2Cleared 510(K)
- K973648MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM2Cleared 510(K)
- K973384ETHICON NON-STICK BIPOLAR FORCEPS2Cleared 510(K)
- K973295BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.4512Cleared 510(K)
- K973190ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES2Cleared 510(K)
- K973341HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE2Cleared 510(K)
- K972510PIVOTAL SCISSOR2Cleared 510(K)
- K973346UNCOATED ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K973158ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE2Cleared 510(K)
- K973297COSMAN COAGULATOR (CC-1) SYSTEM2Cleared 510(K)
- K973173POWERSTAR BIPOLAR SCISSORS2Cleared 510(K)
- K973234MIDAS TOUCH ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K973110LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD2Cleared 510(K)
- K972071BOVIE MODEL X402Cleared 510(K)
- K972558BIPOLAR SCISSORS2Cleared 510(K)
- K973159ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR2Cleared 510(K)
- K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD2Cleared 510(K)
- K972415MINISITE*BIPOLAR FORCEPS** DEVICE2Cleared 510(K)
- K972008ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES2Cleared 510(K)
- K971728PIONEER ELEC-TROCAR DEVICE2Cleared 510(K)
- K972311MODEL 20 BIPOLAR COAGULATOR2Cleared 510(K)
- K972519GRASPING FORCEPS, RIGHT AND LEFT CURVED2Cleared 510(K)
- K972441RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-20002Cleared 510(K)
- K972628THERMOGARD & THERMOGARD PLUS ABC2Cleared 510(K)
- K972497KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES2Cleared 510(K)
- K972299BERGEN MODEL 500 ELECTROSURGERY GENERATOR2Cleared 510(K)
- K964779MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE2Cleared 510(K)
- K972350MODEL 50 BIPOLAR COAGULATOR2Cleared 510(K)
- K971677ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD2Cleared 510(K)
- K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD2Cleared 510(K)
- K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS2Cleared 510(K)
- K971532ARTHROCARE ELECTROSURGERY SYSTEM2Cleared 510(K)
- K971758CAUTERIZATION SMOKE EVACUATOR2Cleared 510(K)
- K9714463M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)2Cleared 510(K)
- K971310AESCULAP JET IRRIGATION SYSTEM2Cleared 510(K)
- K971450SOMNOPLASTY SYSTEM2Cleared 510(K)
- K972269DISPOSABLE PATIENT RETURN ELECTRODE2Cleared 510(K)
- K972273TBD2Cleared 510(K)
- K971711SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K972072SURGITRON MODEL FFPF-EMC2Cleared 510(K)
- K972161BOVIE MODEL X152Cleared 510(K)
- K970809BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL2Cleared 510(K)
- K971805ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE2Cleared 510(K)
- K971674VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST2Cleared 510(K)
- K970797OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES2Cleared 510(K)
- K971341KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR2Cleared 510(K)
- K970993DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE2Cleared 510(K)
- K964329UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)2Cleared 510(K)
- K970987ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K970493HYFRECATOR 20002Cleared 510(K)
- K965199TUNA 5 CATHETER2Cleared 510(K)
- K971092QA-ES2Cleared 510(K)
- K971040CABLE HOLDER, SUCTION TUBE HOLDER2Cleared 510(K)
- K963646STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW2Cleared 510(K)
- K964849ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM2Cleared 510(K)
- K970184OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES2Cleared 510(K)
- K970576SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)2Cleared 510(K)
- K970826SELECTA-TIP LAPAROSCOPIC SCISSORS2Cleared 510(K)
- K970541AESCULAP MODULAR MONOPOLAR ELECTRODES2Cleared 510(K)
- K970140E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH2Cleared 510(K)
- K970130HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING2Cleared 510(K)
- K964636FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM2Cleared 510(K)
- K965241BIPOLAR SUCTION COAGULATOR2Cleared 510(K)
- K964736BERGEN 610 BIPOLAR COAGULATOR2Cleared 510(K)
- K970039ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)2Cleared 510(K)
- K965243ENDOCARE ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K970066UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE2Cleared 510(K)
- K965086CYGNUS ELECTROSURGICAL TIP CLEANER2Cleared 510(K)
- K965007ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES2Cleared 510(K)
- K963765STRYKER STRYKEFLOW ELECTROCAUTERY PROBES2Cleared 510(K)
- K965061VIDAMED MODEDL 7600 RF GENERATOR2Cleared 510(K)
- K965054PENCIL2Cleared 510(K)
- K963930CTS MIDCAB/SVH BIPOLAR SCISSORS2Cleared 510(K)
- K964602DAVIS BAYONET ELECTRODES2Cleared 510(K)
- K964143MINI-SYMM BIPOLAR COAGULATOR2Cleared 510(K)
- K963985UM-D3000/UM-D40002Cleared 510(K)
- K964621A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON2Cleared 510(K)
- K963884SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 3502Cleared 510(K)
- K964071ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR2Cleared 510(K)
- K964175VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES2Cleared 510(K)
- K963189ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES2Cleared 510(K)
- K963783MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE2Cleared 510(K)
- K961334HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE2Cleared 510(K)
- K962593ELECTROSURGICAL PROBES & DEVICES2Cleared 510(K)
- K963901ELECTROSURGICAL PROBE2Cleared 510(K)
- K962690E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE2Cleared 510(K)
- K963772SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)2Cleared 510(K)
- K963338UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH2Cleared 510(K)
- K963180VIDAMED RF GENERATOR DATA RECORDER2Cleared 510(K)
- K963499MIRROR FINISH BIPOLAR FORCEPS2Cleared 510(K)
- K963123ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)2Cleared 510(K)
- K961647DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL2Cleared 510(K)
- K960918VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM2Cleared 510(K)
- K961771AUTO SUTURE SURGIWAND2Cleared 510(K)
- K962692ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE2Cleared 510(K)
- K963157ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)2Cleared 510(K)
- K963088SHEATH, ELECTROSURGICAL PENCIL2Cleared 510(K)
- K962935UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE2Cleared 510(K)
- K962044VALLEYLAB COATED ELECTRODES2Cleared 510(K)
- K962678BIPOLAR PENCIL COAGULATOR2Cleared 510(K)
- K962119RE-NEW LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K955792WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA02Cleared 510(K)
- K961264ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION2Cleared 510(K)
- K961505BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE2Cleared 510(K)
- K955834SYSTEM 6500 ABC ELECTROSURGICAL UNIT2Cleared 510(K)
- K961133SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE2Cleared 510(K)
- K961197SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES2Cleared 510(K)
- K962030KARL STORZ REMORGIDA FORCEPS2Cleared 510(K)
- K961812ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES2Cleared 510(K)
- K961097ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES2Cleared 510(K)
- K961616TELESCOPING PENEVAC (MODIFICATION)2Cleared 510(K)
- K961132SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE2Cleared 510(K)
- K961087DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS2Cleared 510(K)
- K961473HM-88011 SOLID STATE ELECTR SURGICAL UNIT2Cleared 510(K)
- K960695MODEL 200C ELECTROSURGICAL PROBE2Cleared 510(K)
- K960694ZOMED 30F ELECTROSURGICAL PROBE2Cleared 510(K)
- K954171ARCO-MBC, ARCO MC2Cleared 510(K)
- K955166PENEVAC SI.2Cleared 510(K)
- K955020PENEVAC ABC HANDPIECE2Cleared 510(K)
- K955144RADIOTHERAPEUTICS RF GENERATOR MODEL RF-10002Cleared 510(K)
- K960476ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE2Cleared 510(K)
- K955352SUCTION CAUTERY PROBE2Cleared 510(K)
- K960255CERAMIC BLADE ELECTRODE2Cleared 510(K)
- K960808CONMED SELECT ONE LAPAROSCOPY ELECTRODE2Cleared 510(K)
- K960569DISPOSABLE PATIENT RETURN ELECTRODE2Cleared 510(K)
- K943014BALLOON ELECTROSURGICAL PROBES AND DEVICES2Cleared 510(K)
- K960009STORZ S2050 SERIES BIPOLAR FORCEPS2Cleared 510(K)
- K960554DETACHATIP THORACOSCOPIC SCISSORS2Cleared 510(K)
- K955764VALLEY FORGE BIPLOAR LOOP2Cleared 510(K)
- K960455BIPOLAR SUCTION COAGULATOR2Cleared 510(K)
- K9602964000 ETM2Cleared 510(K)
- K955623OLYMPUS BIPOLAR FORCEPS2Cleared 510(K)
- K955681AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE2Cleared 510(K)
- K955167SURGITRON2Cleared 510(K)
- K955836VALLEYLAB COATED ELECTRODES2Cleared 510(K)
- K955261NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)2Cleared 510(K)
- K955163DISSECTION PROBE2Cleared 510(K)
- K955618BIPOLAR CUTTER2Cleared 510(K)
- K955168SURGICAL CUTTER2Cleared 510(K)
- K953271ELMED RF-ALERT2Cleared 510(K)
- K955501THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP2Cleared 510(K)
- K955502THE TULIP MONO POLAR ROTATABLE METZ SCISSORS2Cleared 510(K)
- K955467NEUROVIEW COAXIAL BIPOLAR ELECTRODE2Cleared 510(K)
- K955109VL2600 HANDSWITCHING PENCIL WITH HOLSTER2Cleared 510(K)
- K954965ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES2Cleared 510(K)
- K954439ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE2Cleared 510(K)
- K955001EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS2Cleared 510(K)
- K955346VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM2Cleared 510(K)
- K953696COAGULATING CANNULA DEVICE2Cleared 510(K)
- K955035VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K952231EMC MODEL STATOME 2002Cleared 510(K)
- K954229ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX2Cleared 510(K)
- K954851BIOPOLAR FORCEPS LINE2Cleared 510(K)
- K954871LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM2Cleared 510(K)
- K954253STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS2Cleared 510(K)
- K953081BEAMER PLUS2Cleared 510(K)
- K954633CONMED ELECTROSURGICAL GROUNDING PAD2Cleared 510(K)
- K953992LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE2Cleared 510(K)
- K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD2Cleared 510(K)
- K953738ERBOTOM ICC 3002Cleared 510(K)
- K954321ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)2Cleared 510(K)
- K953479BIPOLAR FORCEPS2Cleared 510(K)
- K953159ERBOTOM ICC BIPOLAR2Cleared 510(K)
- K952072ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE2Cleared 510(K)
- K954056UNIVERSAL PLUS ES S/I INSTRUMENT2Cleared 510(K)
- K953446AESCULAP BIPOLAR CORDS2Cleared 510(K)
- K945914BIPOLAR GENERATOR MODEL 23522Cleared 510(K)
- K954088TELESCOPING PENEVAC2Cleared 510(K)
- K954122TAKE-APART SCISSORS2Cleared 510(K)
- K952973THE TULIP MONO-POLAR CAUTERY SPATULA2Cleared 510(K)
- K952792PADLESS ELECTROSURGICAL PENCIL2Cleared 510(K)
- K953737VL7600 REM PATIENT RETURN ELECTRODE2Cleared 510(K)
- K953195VALLEYLAB FORCE 3002Cleared 510(K)
- K953007EXCALIBUR PLUS ELECTROSURGICAL UNIT2Cleared 510(K)
- K952698ENDOCARE ELECTROSURGICAL HANDPIECE2Cleared 510(K)
- K952110ELMED THERMO-FLUX2Cleared 510(K)
- K944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS2Cleared 510(K)
- K952832DISPOSABLE BIPOLAR ELECTRODE2Cleared 510(K)
- K952587ENDOCARE MONOPOLAR ELECTRODES2Cleared 510(K)
- K951905SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE2Cleared 510(K)
- K952432SYMBIOSIS BIPOLAR FORCEPS2Cleared 510(K)
- K952161BIPOLAR COAGULATION INSTRUMENT2Cleared 510(K)
- K952524AESCULAP BIOPOLAR COAGULATOR2Cleared 510(K)
- K952726ULTRACISION HARMONIC SCAPEL2Cleared 510(K)
- K951659ZOMED MODEL 10 CAUTERY BIOPSY DEVICE2Cleared 510(K)
- K952577ELECTROSURGICAL DISPERSIVE ELECTRODE2Cleared 510(K)
- K951230MICROSURGE BIPOLAR GRASPERS2Cleared 510(K)
- K950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR2Cleared 510(K)
- K945688VALLEYLAB PROCISION(TM) SYSTEM2Cleared 510(K)
- K951245VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY2Cleared 510(K)
- K946237ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES2Cleared 510(K)
- K946177VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM2Cleared 510(K)
- K945254ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES2Cleared 510(K)
- K944602VALLEYLAB FORCE FX2Cleared 510(K)
- K952204CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES2Cleared 510(K)
- K951732NEZHAT-DORESEY PENCIL-GRIP HANDLES2Cleared 510(K)
- K951985PRECISION BIPOLAR COAGULATOR2Cleared 510(K)
- K950663BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR2Cleared 510(K)
- K951731NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS2Cleared 510(K)
- K951912DISOPOSABLE & RESUABLE MONPOLAR CORD2Cleared 510(K)
- K944265NEEDLE ELCTRODE2Cleared 510(K)
- K951589MANUAL SURGICAL INSRUMENT2Cleared 510(K)
- K951328LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD2Cleared 510(K)
- K951269DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL2Cleared 510(K)
- K945758HI-TIP HIGH TEMPERATURE REPLACEMENT TIP2Cleared 510(K)
- K950406DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES2Cleared 510(K)
- K941435BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD2Cleared 510(K)
- K951035BIPOLAR FORCEPS2Cleared 510(K)
- K951032FINESS I (DERMATOLOGIC APPLICATION)2Cleared 510(K)
- K951353HYBRID SURGICAL DEVICES, MODIFICIATION2Cleared 510(K)
- K946105ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES2Cleared 510(K)
- K946104SMOKIEVAC ELECTROSURGICAL PENCIL2Cleared 510(K)
- K946377ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES2Cleared 510(K)
- K950932BIPOLAP HOOK ELECTRODE2Cleared 510(K)
- K950953KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE2Cleared 510(K)
- K950877REUSABLE MONOPOLAR FORCEPS2Cleared 510(K)
- K946246SURGI-LINK BIPOLAR MICRO FORCEPS2Cleared 510(K)
- K950507NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS2Cleared 510(K)
- K950347LEVEEN NEEDLE ELECTRODE(TM)2Cleared 510(K)
- K945694NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS2Cleared 510(K)
- K950188VALLEYLAB COATED ELECTRODES2Cleared 510(K)
- K945531BLADE ELECTRODE2Cleared 510(K)
- K945317NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES2Cleared 510(K)
- K945995BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS2Cleared 510(K)
- K945492HIGH TEMPERATURE CAUTERY2Cleared 510(K)
- K945760HIGH TEMPERATURE CAUTERY2Cleared 510(K)
- K945765HIGH TEMPERATURE CAUTERY2Cleared 510(K)
- K945757HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE2Cleared 510(K)
- K945759HIGH TEMPERATURE CAUTERY 5 LOOP2Cleared 510(K)
- K944681LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES2Cleared 510(K)
- K945975EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS2Cleared 510(K)
- K944012ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR2Cleared 510(K)
- K943055ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES2Cleared 510(K)
- K945893DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE2Cleared 510(K)
- K945898ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES2Cleared 510(K)
- K945805WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE2Cleared 510(K)
- K945717ELECTROSURGICAL ENDOSCOPIC CORD2Cleared 510(K)
- K944634ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES2Cleared 510(K)
- K944642ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES2Cleared 510(K)
- K944578BIPOLAR CORD2Cleared 510(K)
- K944363MODEL PBD ESU PENCIL2Cleared 510(K)
- K944244MODEL E278OR-ASP SERIES RETRACTABLE2Cleared 510(K)
- K942710DISPOSABLE BIPOLAR COAGULATING FORCEPS2Cleared 510(K)
- K942080SENSATEC ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K945380KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS2Cleared 510(K)
- K944030DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K942077BI-TEC ENDOSCOPIC BIPOLAR INSTRUMENTS2Cleared 510(K)
- K945299DISPOSABLE & REUSABLE CHUCK HANDLE2Cleared 510(K)
- K945260E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS2Cleared 510(K)
- K944817NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)2Cleared 510(K)
- K945030SURGI-LINK LAPAROSCOPIC ELECTRODES2Cleared 510(K)
- K944823KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES2Cleared 510(K)
- K944796KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES2Cleared 510(K)
- K942821MAHE INSTRUMENTS2Cleared 510(K)
- K944898SURGI-LINK BIPOLAR ELECTRODES2Cleared 510(K)
- K944784MINI-OP LAPAROSCOPIC LASSO2Cleared 510(K)
- K944706REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K944775ELECTROSURGICAL UNIT MODEL 26-03352Cleared 510(K)
- K944530KARL STORZ INSULATED SCISSORS AND RECTAL SNARES2Cleared 510(K)
- K944370O-R-EZ TIP CLEANER2Cleared 510(K)
- K944617SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL2Cleared 510(K)
- K942944IRRIGATION/BIPOLAR SET2Cleared 510(K)
- K944433SURGI-LINK ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K943865FORCE GSU-SLPM SYSTEM2Cleared 510(K)
- K942579FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-222Cleared 510(K)
- K944045SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS2Cleared 510(K)
- K943991O-R-EZ TIP CLEANER2Cleared 510(K)
- K943542ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE2Cleared 510(K)
- K943818MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS2Cleared 510(K)
- K940750INNERVISION,INC. LAPAROSCOPIC ELECTRODES2Cleared 510(K)
- K941337FLOWGUN ELECTROCAUTERY PROBES2Cleared 510(K)
- K942627454A ELECTROSURGICAL ANALYZER2Cleared 510(K)
- K943231BIOPLAR FORCEPS2Cleared 510(K)
- K942577SURGICAL TIP CLEANER2Cleared 510(K)
- K942489ELECTROSURGICAL CUTTING & COAGULATION DEVICE2Cleared 510(K)
- K936249MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES2Cleared 510(K)
- K936246MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES2Cleared 510(K)
- K942957O-R-EZ TIP CLEANER2Cleared 510(K)
- K942892CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE2Cleared 510(K)
- K942915ELECTROSURGICAL LAPAROSCOPIC INSTRUMENT2Cleared 510(K)
- K942607LAPAROSCOPIC SCISSORS (DISPOSABLE)2Cleared 510(K)
- K941721EMC MODEL NO. 322870 ENDOSTAT2Cleared 510(K)
- K942499INSULATED SURGICAL ELECTRODE2Cleared 510(K)
- K941897ULTRACISON HARMONIC SCALPEL HS2 BLADE2Cleared 510(K)
- K941426SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE2Cleared 510(K)
- K932632CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION2Cleared 510(K)
- K936036KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION2Cleared 510(K)
- K936304ELECTROSURGICAL PENCIL2Cleared 510(K)
- K942319HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES2Cleared 510(K)
- K936075REUSABLE, HAND CONTROLLED ESP2Cleared 510(K)
- K940955REFLEX EGR2Cleared 510(K)
- K942215CONMED ELECTROSURGICAL GROUNDING PADS2Cleared 510(K)
- K942194QUANTUM BI-POLAR ELECTROSURGICAL CABLE2Cleared 510(K)
- K941908QUANTUM MONO-POLAR ELECTROSURGICAL CABLE2Cleared 510(K)
- K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY2Cleared 510(K)
- K942183E2550 REUSABLE HANDSWITCHING PENCIL2Cleared 510(K)
- K935971FLOWGUN ELECTROCAUTERY PROBES2Cleared 510(K)
- K935970FLOWGUN ELECTROCAUTERY PROBE HANDLE2Cleared 510(K)
- K941968VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC2Cleared 510(K)
- K940552MONOPOLAR SURGICAL INSTRUMENTS2Cleared 510(K)
- K940299ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD2Cleared 510(K)
- K932938ELMED ESU 300 M/M AND DIGITAL2Cleared 510(K)
- K940466TITANIUM BIPOLAR FORCEPS2Cleared 510(K)
- K941160CONMED T.D.S. ELECTROSURGICAL GROUND PAD2Cleared 510(K)
- K940936AESCULAP ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K940192MIS ELECTROSURGICAL ELECTRODES2Cleared 510(K)
- K940219TRIGEL- MULTIFUNCTION ELECTRODE2Cleared 510(K)
- K935490ELECTROSURGICAL DEVICE, MODEL 26-25002Cleared 510(K)
- K935815ERBOTOM ICC 502Cleared 510(K)
- K940909ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE2Cleared 510(K)
- K935222STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES2Cleared 510(K)
- K935237STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K930243FLEXIBLE EXTENDER2Cleared 510(K)
- K924057DISPOSIBLE ELECTRO COAGULATION PROBE2Cleared 510(K)
- K933002ERBOTOM ICC 3502Cleared 510(K)
- K932817HM-880 I2Cleared 510(K)
- K935874COOK COAGULATOR PROBE2Cleared 510(K)
- K934828CONMED UNIVERSAL PLUS2Cleared 510(K)
- K934784ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE2Cleared 510(K)
- K935091ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE2Cleared 510(K)
- K934281PHX TECHNOLOGIES CORP.,HOOK ELECTRODE, 5MM2Cleared 510(K)
- K932818HM-8802Cleared 510(K)
- K933728JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-3392Cleared 510(K)
- K933157ERBOTOM ICC 2002Cleared 510(K)
- K935105REFLEX ESP WITH FINGER SWITCHES2Cleared 510(K)
- K932654ELECTROSURGIAL INSTRUMENTS2Cleared 510(K)
- K934985ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD2Cleared 510(K)
- K934800CONMED SELECTONE SURGICAL INSTRUMENTS2Cleared 510(K)
- K934656CONMED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUNDING PADS2Cleared 510(K)
- K933131BISTAT 70/70-I ELECTROSURGICAL UNIT2Cleared 510(K)
- K926481VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET2Cleared 510(K)
- K925850DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS2Cleared 510(K)
- K933699GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K934427PILLING LAPAROSCOPIC INSTRUMENTATION2Cleared 510(K)
- K934075ISI METZENBAUM SCISSORS2Cleared 510(K)
- K934035GM MONOPOLAR/FRAZIER SUCTION PROBE2Cleared 510(K)
- K932392PHX TECHNOLOGIES CORP ELECTROSURGICAL PROBES2Cleared 510(K)
- K926297REFLEX ESI2Cleared 510(K)
- K926242ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE2Cleared 510(K)
- K926203ENDOSCOPIC SCISSORS (DISPOSABLE/REUSABLE SHAFTS)2Cleared 510(K)
- K932518TECH-SWITCH ELECTROSURGICAL PENCIL, REUSABLE2Cleared 510(K)
- K931982NEW ENGLAND MEDICAL GROUNDING PAD2Cleared 510(K)
- K931959JARIT SURGICAL INSTRUMENTS2Cleared 510(K)
- K925647VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE2Cleared 510(K)
- K933332MODEL 6400 ABC ELECTROSURGERY GENERATOR2Cleared 510(K)
- K932102ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K926103POLYP SNARE NET W/MONOPOLAR CAUTERY2Cleared 510(K)
- K931885DRIGEL MULTIFUNCTION ELECTRODE2Cleared 510(K)
- K931537A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT2Cleared 510(K)
- K930097ELECTROCAUTERY SHROUD2Cleared 510(K)
- K931028VALLEYLAB RETRACTABLE ELECTRODES2Cleared 510(K)
- K931480CLEANBLADE2Cleared 510(K)
- K924881REFLEX(R) ESP2Cleared 510(K)
- K921271ELECTROSURGICAL UNIT2Cleared 510(K)
- K930497ARGON HANDPIECES2Cleared 510(K)
- K924410LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION2Cleared 510(K)
- K924028LAPAROSCOPIC SURGICAL INSTRUMENT2Cleared 510(K)
- K925984ACUCISE ELECTROSURGICAL TROCAR2Cleared 510(K)
- K922576AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K930355MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS2Cleared 510(K)
- K925707INSTRUMENT, MANUAL, GENERAL SURGICAL2Cleared 510(K)
- K925851COOK TISSUE MORCELLATOR2Cleared 510(K)
- K924917HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY2Cleared 510(K)
- K930528A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS2Cleared 510(K)
- K926414VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E32002Cleared 510(K)
- K925830MICROSURGE SUCTION/IRRIGATION SYSTEM2Cleared 510(K)
- K921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M2Cleared 510(K)
- K926415VALLEYLAB CURRENT MONITOR, E3350 & E33512Cleared 510(K)
- K924960EXCALIBUR ELECTROSURGICAL UNIT2Cleared 510(K)
- K925266SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES2Cleared 510(K)
- K924469GRASPERS & SCISSORS (MINIMAL ACCESS SURG INSTR)2Cleared 510(K)
- K924283MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS2Cleared 510(K)
- K924524FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER2Cleared 510(K)
- K925130NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)2Cleared 510(K)
- K925150MODIFIED ARTICULATING ENDOSCOPIC CLAMP2Cleared 510(K)
- K926306FOOT CONTROL PENCIL2Cleared 510(K)
- K924918FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)2Cleared 510(K)
- K922802MICROSURGE FRONT-END GRASPING DEVICES2Cleared 510(K)
- K923928BIPOLAR COAGULATOR/IRRIAGATION SYSTEM2Cleared 510(K)
- K922289SESQUIPOLAR(TM) MIS ELECTRODE2Cleared 510(K)
- K914883CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG2Cleared 510(K)
- K922062THE DENVER CAUTERY2Cleared 510(K)
- K925903LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION2Cleared 510(K)
- K925619DISPOSABLE HAND-SWITCHING ESU PENCIL2Cleared 510(K)
- K924188BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM2Cleared 510(K)
- K922999SEGAL REUSABLE ELECTRODE2Cleared 510(K)
- K923845DEXIDE LAPAROSCOPIC ACCESSORIES2Cleared 510(K)
- K923563SYMBIOSIS SUCTION-IRRIGATOR2Cleared 510(K)
- K923416O.R. CONCEPTS' ELECTROSURGICAL PROBE2Cleared 510(K)
- K923199O.R. CONCEPTS ELECTROSURGICAL PROBES2Cleared 510(K)
- K922423ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.2Cleared 510(K)
- K921696CUTTING AND COAGULATION DEVICES AND ACCESSORIES2Cleared 510(K)
- K922425ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM2Cleared 510(K)
- K920166MODULAR DESIGN ELECTROSURGICAL LAPAROSCOPY INTR2Cleared 510(K)
- K915731ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL2Cleared 510(K)
- K923332ELECTROSURGICAL ELECTRODES2Cleared 510(K)
- K914193A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT2Cleared 510(K)
- K922509LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA2Cleared 510(K)
- K922523BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS2Cleared 510(K)
- K924264O.R. CONCEPTS CABLE HARNESS2Cleared 510(K)
- K915296MONOPOLAR ELECTRODE2Cleared 510(K)
- K922002SUCTION IRRIGATION CAUTERY PROBE2Cleared 510(K)
- K921921CATHETER CHOLANGIOGRAPHY2Cleared 510(K)
- K922090FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION2Cleared 510(K)
- K920217MAX-E-VAC2Cleared 510(K)
- K915608BICUT2Cleared 510(K)
- K920071MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-152Cleared 510(K)
- K915204MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT2Cleared 510(K)
- K915826BIO-POLAR FORCEPS2Cleared 510(K)
- K912070SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT2Cleared 510(K)
- K912611OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE2Cleared 510(K)
- K920185GENESIS ELECTROSURGICAL UNIT2Cleared 510(K)
- K914928BASIC SET UP TRAY2Cleared 510(K)
- K915788MIS ELECTROSURGICAL ELECTRODES2Cleared 510(K)
- K913623SURGICAL ELECTRICAL PENCIL2Cleared 510(K)
- K915300A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES2Cleared 510(K)
- K913799LM-90 ESU2Cleared 510(K)
- K914910DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)2Cleared 510(K)
- K913625ELECTROSCOPE MONITOR, EM-12Cleared 510(K)
- K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD2Cleared 510(K)
- K912781ELECTROSHIELD2Cleared 510(K)
- K913108TEFLON COATED ELECTRODES/ELECTRODES HANDLES2Cleared 510(K)
- K914252ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K914066ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS2Cleared 510(K)
- K910978ACCU-BEAM LAPAROSCOPIC SYSTEM2Cleared 510(K)
- K913514ELECTROSURGICAL UNIT CABLE2Cleared 510(K)
- K914400MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS2Cleared 510(K)
- K912637LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE2Cleared 510(K)
- K914132WILTEK ELECTROCAUTERY ACTIVE CORD2Cleared 510(K)
- K914131WILTEK ELECTROCAUTERY ADAPTOR2Cleared 510(K)
- K912968ELEC SURG INSTR FOR LOPPROSCOPE CHOLECYSTECYOMY2Cleared 510(K)
- K912229IMA ELECTROCAUTERY ELECTRODE CAT. #60002/600032Cleared 510(K)
- K911312SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL2Cleared 510(K)
- K912614ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K912656ENDOSCOPIC ELECTRODE2Cleared 510(K)
- K913473E-Z CLEAN ELECTRODE2Cleared 510(K)
- K912597ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K912182MEDITRON COMBINATION GENERATOR CG-20002Cleared 510(K)
- K910889ABC LAPAROSCOPIC HANDPROBE2Cleared 510(K)
- K913281E-Z CLEAN LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K912337ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS2Cleared 510(K)
- K911904MODELS UES-10 & PSD-102Cleared 510(K)
- K905752ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K911787MONOPOLAR SPHINCTERTOME2Cleared 510(K)
- K911491LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K911476LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION2Cleared 510(K)
- K910074LAPAROMED HOOK/SPATULA DEVICE2Cleared 510(K)
- K910939COOK TISSUE MORCELLATOR2Cleared 510(K)
- K911341HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO2Cleared 510(K)
- K911274UNIPOLAR COAGULATOR PROBE SYSTEM2Cleared 510(K)
- K911365ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS2Cleared 510(K)
- K910831ENDOPATH SURGICAL INSTRUMENTS2Cleared 510(K)
- K910663BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-13052Cleared 510(K)
- K911316INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA2Cleared 510(K)
- K910779DISPOSABLE ELECTROSURGICAL BLADE2Cleared 510(K)
- K910510VALLEY FORGE BIPOLAR PEN OR FORCEPS2Cleared 510(K)
- K911377FORCEPS, COAGULATION, BIPOLAR, MALIS2Cleared 510(K)
- K905654ELECTROSURGICAL UNIT WITH ACCESSORIES2Cleared 510(K)
- K905605FORCE 10, 20, 30, AND 402Cleared 510(K)
- K910334ELECTROCAUTERY PROBE2Cleared 510(K)
- K910184PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES2Cleared 510(K)
- K905529VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE2Cleared 510(K)
- K905315ULTRACISION HARMONIC SCALPEL2Cleared 510(K)
- K905108CONTORNO(R), MODELS E AND ST2Cleared 510(K)
- K904993LAPAROSCOPIC ELECTROSURGICAL DEVICE2Cleared 510(K)
- K904808ELECTROSURGICAL PENCIL2Cleared 510(K)
- K904560VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES2Cleared 510(K)
- K904545FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET2Cleared 510(K)
- K904506ACTIVE ADAPTER2Cleared 510(K)
- K902996ARGON BEAM LAPAROSCOPIC ELECTRODE2Cleared 510(K)
- K903610O.R. TIP CLEANER2Cleared 510(K)
- K903127SURGITEK(R) TURP MONITOR2Cleared 510(K)
- K903724BEAMER 1,2,4,6, AND 82Cleared 510(K)
- K903812ELECTROPROBE SINGLE-USE SURGICAL PROBE2Cleared 510(K)
- K903006ELECTROSURGICAL BIPOLAR FORCEPS2Cleared 510(K)
- K903855THE ON-GARD CORD-CADDY2Cleared 510(K)
- K902307SHAW II HEMOSTATIC SURGERY SYSTEM2Cleared 510(K)
- K902642CONTORNO (TM)2Cleared 510(K)
- K902735SD SNARES2Cleared 510(K)
- K902232WECK ELECTROSURGICAL GENERATOR #1742002Cleared 510(K)
- K902035FLEXIBLE EXTENDER2Cleared 510(K)
- K901302BIPOLARD POLYPECTOMY SYSTEM (TM)2Cleared 510(K)
- K901145NDM SWITCHPEN HOLSTER2Cleared 510(K)
- K900633DISP. ELECTROSURGERY PENCIL, HAND CONTROL2Cleared 510(K)
- K900767B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE2Cleared 510(K)
- K900953GS-5000 SPATULA SUCTION/COAGULATOR, 5MM2Cleared 510(K)
- K900949GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATED2Cleared 510(K)
- K900947GS-1000 GRASPING FORCEP, 5MM, INSULATED2Cleared 510(K)
- K900954GS-5200 HOOK SUCTION/COAGULATOR, 5MM2Cleared 510(K)
- K900347BIRTCHER FOOTCONTROLLED SUCTION COAGULATOR2Cleared 510(K)
- K900533DISPOSABLE BIPOLAR COAGULATING FORCEPS2Cleared 510(K)
- K900714ZZIPP INSTANT BOVIE CLEANER2Cleared 510(K)
- K900629BERNSCO LUER NEEDLER ADAPTOR2Cleared 510(K)
- K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE2Cleared 510(K)
- K896055ERBOTOM ACC 4502Cleared 510(K)
- K896839MF-450 ELECTROSURGICAL UNIT 60-5500-0012Cleared 510(K)
- K896541MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III2Cleared 510(K)
- K896626HAND CONTROLLED ELECTROSURGICAL PENCILS2Cleared 510(K)
- K895841MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.2Cleared 510(K)
- K895737THE DOCTOR'S CHOICE ELECTRODE2Cleared 510(K)
- K895252ULTRACISION ULTRASONIC SCALPEL2Cleared 510(K)
- K894166THERMOSURGERY TM2Cleared 510(K)
- K894602B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)2Cleared 510(K)
- K893732ASPEN DISPOSABLE BIPOLAR CORD2Cleared 510(K)
- K893659ELECTROSURGERY ANALYZER RF3022Cleared 510(K)
- K892502ELECTROSURGICAL PENCIL2Cleared 510(K)
- K890648MALIS BIPOLAR CORD/IRRIGATION TUBING SET2Cleared 510(K)
- K885200600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE2Cleared 510(K)
- K885199#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES2Cleared 510(K)
- K885172ADDITIONAL ELECTROSURGICAL GROUND PADS2Cleared 510(K)
- K884641BOVAC SMOKE COLLECTOR2Cleared 510(K)
- K884836UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-30002Cleared 510(K)
- K884656DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP2Cleared 510(K)
- K883823BERNSCO ELECTROSURGICAL SHIELD2Cleared 510(K)
- K883774BERNSCO NEEDLE ADAPTER2Cleared 510(K)
- K883762BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE2Cleared 510(K)
- K883396HANDSWITCHING MONOPOLAR PENCIL2Cleared 510(K)
- K882049MEDITRON MG-1000 MONOPOLAR GENERATOR2Cleared 510(K)
- K883060STORZ MICROSURGICAL BIPOLAR COAGULATOR2Cleared 510(K)
- K882903YESNG SUPER FRECATOR2Cleared 510(K)
- K882742FIBER OPTIC LIGHT SOURCE CAT. #E91002Cleared 510(K)
- K882646LECTROBRASIVE(R) E24012Cleared 510(K)
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- K881687CAVITRON ELECTROSURGICAL MODULE (CEM) AND PAK2Cleared 510(K)
- K881460SMOKEVAC ELECTORSURGICAL PENCIL2Cleared 510(K)
- K881413ELECTRO-CAUTERY SUCTION TUBE2Cleared 510(K)
- K881427SPIRIX(TM)2Cleared 510(K)
- K880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-12002Cleared 510(K)
- K881408YESNG REUSABLE ELECTROSURGICAL HANDLE2Cleared 510(K)
- K881406YESNG REUSABLE ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K881407YESNG RESUABLE BIPOLAR FORCEPS2Cleared 510(K)
- K880073YESNG MODEL 500SII ELECTROSURGICAL UNIT2Cleared 510(K)
- K880064YESNG MODEL 200S11 ELECTROSURGICAL UNIT2Cleared 510(K)
- K874825DISPOSABLE CAUTERIES2Cleared 510(K)
- K874798MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION2Cleared 510(K)
- K874775ELECTRODE TIP CLEANER2Cleared 510(K)
- K874779BIPOLATOR 502Cleared 510(K)
- K873595SURGICAL PENCIL/ ELECTROSURGICAL PENCIL2Cleared 510(K)
- K873591A.R.M. (ASPEN RETURN MONITOR)2Cleared 510(K)
- K872705BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)2Cleared 510(K)
- K871077MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.2Cleared 510(K)
- K871910SURGITEK DISPOSABLE BIPOLAR CORD2Cleared 510(K)
- K870981MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K870149MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.2Cleared 510(K)
- K870397AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY2Cleared 510(K)
- K870269ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-1002Cleared 510(K)
- K864771CHUCK HANDLE2Cleared 510(K)
- K864402BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE2Cleared 510(K)
- K864851MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K864675MODEL FORCE 4B ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K863731ROTARY* POWERED SCALPEL2Cleared 510(K)
- K863701MODEL 709 BIPOLAR MICRO COAGULATOR2Cleared 510(K)
- K862753TANDEM SUCTION CAUTERY2Cleared 510(K)
- K863413BIPOLFORCEPS2Cleared 510(K)
- K863412BIPOL CABLE2Cleared 510(K)
- K863414MICROBIPOLATOR2Cleared 510(K)
- K863360NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE2Cleared 510(K)
- K862221E-Z CLEAN2Cleared 510(K)
- K861742ELECTRO-SURGICAL PENCILS2Cleared 510(K)
- K861614GHI WET PENCIL2Cleared 510(K)
- K861594ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE)2Cleared 510(K)
- K861595BALL ELECTRODES2Cleared 510(K)
- K861495ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE)2Cleared 510(K)
- K861372ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY2Cleared 510(K)
- K861112MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS2Cleared 510(K)
- K861139ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)2Cleared 510(K)
- K861036E7509 POLYHESIVE II PATIENT RETURN ELECTRODE2Cleared 510(K)
- K855084PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD2Cleared 510(K)
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- K853972CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR2Cleared 510(K)
- K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 332Cleared 510(K)
- K854864BI-POLAR FORCEPS2Cleared 510(K)
- K854592MALIS MICRO BIPOLAR COAGULATOR2Cleared 510(K)
- K854413MALIS IRRIGATION SYSTEM2Cleared 510(K)
- K853968DIATEMP ELECTROSURGICAL PEN2Cleared 510(K)
- K852942WORLD PORTABLE CAUTERY2Cleared 510(K)
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- K851305NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,2Cleared 510(K)
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- K853168MALIS BIPOLAR PEN2Cleared 510(K)
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- K851040CONCEPT DEFRERE ELECTRODE2Cleared 510(K)
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- K850668ELECTROSURGICAL UNIT 7742Cleared 510(K)
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- K843974VARIABLE TEMPERATURE CAUTERY DEVICE2Cleared 510(K)
- K844565BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)2Cleared 510(K)
- K844372HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE2Cleared 510(K)
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- K844371HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE2Cleared 510(K)
- K844004ESCHMANN TDB50 BIPOLAR COAGULATION2Cleared 510(K)
- K841603ADJUST-A-TEMP MICRO2Cleared 510(K)
- K841604ADJUST-A-TEMP HIGH TEMPERATURE2Cleared 510(K)
- K841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.2Cleared 510(K)
- K841459REPLACE-A-TIP ADJUST. LOW TEMP.-2Cleared 510(K)
- K841591PYRO-TIP2Cleared 510(K)
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- K842622HEMO STATIC/ESU SCALPEL SYSTEM2Cleared 510(K)
- K841483ALL PURPOSE ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K842596MICROPENCIL2Cleared 510(K)
- K842595MICROELECTRODE2Cleared 510(K)
- K842574THE CLINICIAN2Cleared 510(K)
- K840387SURG-A-STAT LOOP TIP 22Cleared 510(K)
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- K840375SURG-A-STAT LOOP TIP 152Cleared 510(K)
- K840433REPLACE-A-TIP HIGH TEMP. CAUTERY2Cleared 510(K)
- K840434REPLACE-A-TIP LOW TEMP. CAUTERY2Cleared 510(K)
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- K834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO2Cleared 510(K)
- K831489SURGICAL TUBE HOLDER2Cleared 510(K)
- K833449HAND CONTROLLED PENCIL OR SWITCH HAND2Cleared 510(K)
- K833441DRY GEL2Cleared 510(K)
- K8333643M SCOTCHPLATE II DISPERSIVE ELECTRODE2Cleared 510(K)
- K833015BIOPLAR CORD -DISPOSABLE 30-15382Cleared 510(K)
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- K831508MALIS CMC-II BIPOLAR COAGULATOR & CUT2Cleared 510(K)
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- K8236893M SCOTCHPLATE 51148 SMALL CONDUCTIVE2Cleared 510(K)
- K823670E.S. PENCIL2Cleared 510(K)
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- K821505AIRWAY TEMPERATURE SENSOR2Cleared 510(K)
- K823083ELECTROSURGICAL UNIT2Cleared 510(K)
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- K822355DISP. METAL & PLASTIC ELECTROSURG. DEV2Cleared 510(K)
- K822572POLYHESIVE PATIENT RETURN ELECTRODE2Cleared 510(K)
- K822513MODEL #2000 HI-TEMP & #3000 LOW-TEMP2Cleared 510(K)
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- K822072MPI ELECTROSURGICAL CAPACTIVE DISPER2Cleared 510(K)
- K822070ELITE #MPS 101 ELECTROSURGICAL SWITCH2Cleared 510(K)
- K822069ELIMINATOR #BPS 201 BIPOLAR ELECTRO2Cleared 510(K)
- K822062BALL TIP COAGULATING ELECTRODES2Cleared 510(K)
- K821169MPI MON-IT II, SMART SAFETY SYSTEM2Cleared 510(K)
- K821356DESERET CAPACITY PLUS ELECTROSURG. PAD2Cleared 510(K)
- K821263SELECT BIPOLAR COAGULATION FORCEPS2Cleared 510(K)
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- K820983HOT BIOPSY FORCEPS W/ROUND CUPS2Cleared 510(K)
- K820902MULTIPERFECTEMP2Cleared 510(K)
- K820494SYBRON BOVIE CSV HAND CONTR. ELECTROSURG2Cleared 510(K)
- K820713BALLARD MEDICAL PRODUCTS ELECTRO-SURG2Cleared 510(K)
- K820156THEIR ELECTRO SURGICAL COUTERY PENCIL2Cleared 510(K)
- K812760HI-TEMP CARDIOVASCULAR CAUTERY2Cleared 510(K)
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- K813071E2508 DISPOSABLE HANDSWITCHING PENCIL2Cleared 510(K)
- K812769TRIDENT #20012Cleared 510(K)
- K812722SAFE GUARD2Cleared 510(K)
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- K812125LAPIN CLEAR CUT II2Cleared 510(K)
- K812198ACCESSORIES(PROBES, SUCTION TUBES, ETC.)2Cleared 510(K)
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- K810277PREGELLED DISPOS. ELECTROSURG. GROUND EL2Cleared 510(K)
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- K803055ELECTROSURGICAL TIP CLEANER & HOLDER2Cleared 510(K)
- K802942HITEMP. TM 2 LOOPTIP CAUTERY2Cleared 510(K)
- K810101WATER RESISTANT FOOTSWITCH W/CABLE2Cleared 510(K)
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- K802605ELECTRO SURGICAL TIP CLEANER2Cleared 510(K)
- K802330HI-TEMP LOOPTIP SURGICAL CAUTERY2Cleared 510(K)
- K801323HI-TEMP SURGICAL CAUTERY2Cleared 510(K)
- K801158NDM DIATEMP ELECTROSURGICAL DIS. PAD2Cleared 510(K)
- K801153VALLEYLAB RETURN ELECTRODE MONITOR2Cleared 510(K)
- K800617HYFRECATOR, #7332Cleared 510(K)
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- K791868OXIMETRIX SHAW HEMOSTATIC SURG. SYS.2Cleared 510(K)
- K792343DIATHERMIC SNARE (CRESENT TYPE)2Cleared 510(K)
- K792150MODEL 808 ADAPTER2Cleared 510(K)
- K792315A.D.E. ASPEN DISPERSIVE ELECTRODE2Cleared 510(K)
- K792044SAFE RETURN COT. #9675 & CONNECTOR ADAPT2Cleared 510(K)
- K791541EMS ADAPTER MODEL 91602Cleared 510(K)
- K791767BOVIE CSV HAND CONTROL ADAPTER2Cleared 510(K)
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- K791752LECTROVAC, VALLEYLAB MODELS2Cleared 510(K)
- K791638MODEL E2510 SURGISWITCH2Cleared 510(K)
- K791639MODEL E2515 ELECTROSURGICAL ACCESSORY2Cleared 510(K)
- K791362ELECTROSURGICAL CUT AND COAGU ACCESSORY2Cleared 510(K)
- K791230ELECTROSURGICAL GENERATOR (TIM)2Cleared 510(K)
- K791224MALIBU LABS MODEL 800 FINGER TIP CONT2Cleared 510(K)
- K791137SINGLE USE MONOPOLAR HAND CONTROL PENCIL2Cleared 510(K)
- K790770SAFETY HOLSTER, SINGLE-USE2Cleared 510(K)
- K790642LEY ELECTRO-SURGICAL UNITS2Cleared 510(K)
- K790296ELECTRODE, MODEL E7504 PREP II2Cleared 510(K)
- K790293CIMARRON 1000 OR 1000-22Cleared 510(K)
- K790367GRAB-IT2Cleared 510(K)
- K790187BOVIE HAND CONTROL2Cleared 510(K)
- K781949ELECTROSURGERY MODEL 7712Cleared 510(K)
- K781799EKG, SWITCHING BLADE AND PENS2Cleared 510(K)
- K781810ELECTROSURGICAL UNIT 3001-30092Cleared 510(K)
- K781510DISPOSABLE LECTROSWITCH, MODEL E25032Cleared 510(K)
- K781511LECTROSWITCH MODEL E2502B2Cleared 510(K)
- K781429HAND-TROL CONNECTOR EXTENDER2Cleared 510(K)
- K781148ELECTROSURGICAL PENCIL SYSTEM2Cleared 510(K)
- K781101ELECTROSURGICAL UNIT 752Cleared 510(K)
- K780975SINGLE USE NEEDLE ELECTRODE2Cleared 510(K)
- K780976SINGLE USE BALL ELECTRODE2Cleared 510(K)
- K780977SINGLE USE BLADE ELECTRODE2Cleared 510(K)
- K780978SINGLE USE ACTIVE ELECTRODE HANDLE2Cleared 510(K)
- K780924ELECTROSURGICAL GROUNDING PAD CABLE2Cleared 510(K)
- K780298ELECTRO-SURGICAL GROUNDING PAD2Cleared 510(K)
- K780206GENERATOR, ELECTROSURGICAL2Cleared 510(K)
- K772235HAND CONTROL ACCESS.-ELECTROSURG. UNITS2Cleared 510(K)
- K772199CAUTERIES, HOT WIRE, DISP.2Cleared 510(K)
- K771639ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K771352ELECTROSURG. PATIENT GROUNDING PLATE2Cleared 510(K)
- K771007ELECTROSURGICAL POWER GENERATORS2Cleared 510(K)
- K771752FINGER TIP CONTROL PENCIL2Cleared 510(K)
- K771751DISP. ELECTROSURGERY PENCIL2Cleared 510(K)
- K771332PATIENT GROUNDING CABLES2Cleared 510(K)
- K771331CONDUCTIVE ELECTRODE GEL2Cleared 510(K)
- K771330DISP. GROUND PLATE2Cleared 510(K)
- K771329DISP. GROUND PAD PREGELLED2Cleared 510(K)
- K771440MACBICK CONDUCTIVE GEL - 0009072Cleared 510(K)
- K771009ELECTRO-SURGICAL DEVICES2Cleared 510(K)
- K770969CLEV-DENT COLHS ELECTROSURG, MOLEL TR-52Cleared 510(K)
- K770647ELECTROSURGICAL GROUNDING CABLE2Cleared 510(K)
- K770646ELECTROSURGICAL PATIENT GROUNDING PAD2Cleared 510(K)
- K761231MODEL 738 BIRT-A-PAD2Cleared 510(K)
- K761221NON-STERILE PREGELLED GROUNDING PAD2Cleared 510(K)
- K760675ELECTROSURGICAL DISPERSIVE PLATE2Cleared 510(K)
- K760722BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE2Cleared 510(K)
- K760359ELECTRODE, BOVIE DISPERSIVE2Cleared 510(K)
- K760168PENCIL, ELECTROSURGICAL2Cleared 510(K)
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- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.2Product Code
- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
- PFPSilicone Hydrogel For Scar Management1Product Code
- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- SFGCamera, Surgical, Measurement1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BTL-FR2000
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180359
- 510(k) Type
- Traditional
- Applicant
- BTL Industries, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/13/2018
- Days to Decision
- 307 days
- Submission Type
- Summary