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
- K222487Anika Tissue Tack Fixation System2Cleared 510(K)
- K222210AEON Endoscopic Stapler2Cleared 510(K)
- K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)2Cleared 510(K)
- K211197Disposable Endoscopic Cutter Stapler and Cartridge2Cleared 510(K)
- K221771EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip Version2Cleared 510(K)
- K221003Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA2Cleared 510(K)
- K221013GIA Auto Suture Stapler with DST Series Technology2Cleared 510(K)
- K221006GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K221005EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers2Cleared 510(K)
- K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers2Cleared 510(K)
- K201934Surgimatix Absorbable Fixation System2Cleared 510(K)
- K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use2Cleared 510(K)
- K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads2Cleared 510(K)
- K202709Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges2Cleared 510(K)
- K210278Titan SGS2Cleared 510(K)
- K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload2Cleared 510(K)
- K202507EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K203117TissueTak device2Cleared 510(K)
- K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads2Cleared 510(K)
- K202701GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K202864Tri-Staple 2.0 Reloads2Cleared 510(K)
- K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm2Cleared 510(K)
- K201882AEON Endoscopic Stapler2Cleared 510(K)
- K201280Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed2Cleared 510(K)
- K201672Signia Stapler (with new software)2Cleared 510(K)
- K200420Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green2Cleared 510(K)
- K192720GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K192330EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool2Cleared 510(K)
- K182476Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads2Cleared 510(K)
- K190331Applied Medical Laparoscopic Linear Cutter2Cleared 510(K)
- K192566Reach and CQ'ENCE Circular Staplers2Cleared 510(K)
- K191070Signia Small Diameter Reloads2Cleared 510(K)
- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners2Cleared 510(K)
- K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use2Cleared 510(K)
- K182475Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)2Cleared 510(K)
- K181668FasTouch Absorbable Fixation System2Cleared 510(K)
- K183477easyPPHTM Hemorrhoidal Stapler for Single Use2Cleared 510(K)
- K183435Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black2Cleared 510(K)
- K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use2Cleared 510(K)
- K180175SignalMark Lung Biopsy Site Marker2Cleared 510(K)
- K182380AEON Endoscopic Stapler2Cleared 510(K)
- K181653Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed2Cleared 510(K)
- K181620Endoscopic Linear Cutting Staplers and Loading Units for Single Use2Cleared 510(K)
- K173270Tri-Staple 2.0 Reinforced Reload2Cleared 510(K)
- K172361EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K173443AEON Endoscopic Stapler2Cleared 510(K)
- K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use2Cleared 510(K)
- K172561Disposable Circular Stapler2Cleared 510(K)
- K172538Disposable Linear Stapler, Disposable Linear Cutter2Cleared 510(K)
- K171589AEON Endoscopic Stapler2Cleared 510(K)
- K171561Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload2Cleared 510(K)
- K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload2Cleared 510(K)
- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners2Cleared 510(K)
- K163523ECHELON CIRCULAR Powered Stapler2Cleared 510(K)
- K163698OptiFix Open Absorbable Fixation System - 20 absorbable fasteners2Cleared 510(K)
- K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler2Cleared 510(K)
- K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)2Cleared 510(K)
- K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload2Cleared 510(K)
- K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm2Cleared 510(K)
- K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler2Cleared 510(K)
- K163098Tri-Staple 2.0 Intelligent Cartridge2Cleared 510(K)
- K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads2Cleared 510(K)
- K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge2Cleared 510(K)
- K162252FasTouch Fixation System2Cleared 510(K)
- K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload2Cleared 510(K)
- K160900CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners2Cleared 510(K)
- K160176Signia Stapler2Cleared 510(K)
- K153202iMESH Tacker2Cleared 510(K)
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm2Cleared 510(K)
- K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge2Cleared 510(K)
- K152618PANTHER Cutter Stapler2Cleared 510(K)
- K151659ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks2Cleared 510(K)
- K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading Units2Cleared 510(K)
- K151163Signia Loading Unit, Tri-Staple 2.0 Cartridge2Cleared 510(K)
- K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler2Cleared 510(K)
- K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners2Cleared 510(K)
- K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners2Cleared 510(K)
- K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)2Cleared 510(K)
- K141952ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED2Cleared 510(K)
- K141097CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE2Cleared 510(K)
- K141367LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS2Cleared 510(K)
- K140560ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING2Cleared 510(K)
- K140609RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS2Cleared 510(K)
- K131563SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM2Cleared 510(K)
- K132698FASTOUCH FIXATION SYSTEM2Cleared 510(K)
- K140118MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE2Cleared 510(K)
- K140170MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE2Cleared 510(K)
- K132472JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD2Cleared 510(K)
- K133938ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K133499SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA2Cleared 510(K)
- K132669PROXIFAST ABSORBABLE STAPLE2Cleared 510(K)
- K133762ENDO GIA(TM) EXTRA LONG ADAPTER2Cleared 510(K)
- K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE2Cleared 510(K)
- K130738ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS2Cleared 510(K)
- K132134OPTIFIX ABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K132493ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K131663ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK2Cleared 510(K)
- K131637ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)2Cleared 510(K)
- K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR2Cleared 510(K)
- K131705ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K131303DISPOSABLE CIRCULAR STAPLER2Cleared 510(K)
- K130717ENDO GIA RELOAD2Cleared 510(K)
- K130653ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU2Cleared 510(K)
- K123114ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE2Cleared 510(K)
- K122781RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD2Cleared 510(K)
- K123718PERMASORB DISPOSABLE FIXATION DEVICE2Cleared 510(K)
- K123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER2Cleared 510(K)
- K123109ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE2Cleared 510(K)
- K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER2Cleared 510(K)
- K121600ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE2Cleared 510(K)
- K121474DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER2Cleared 510(K)
- K120179REACH SURGICAL STAPLERS2Cleared 510(K)
- K120373INSORB ABSORBALBE STAPLE2Cleared 510(K)
- K120258DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS2Cleared 510(K)
- K120268AMID STAPLER2Cleared 510(K)
- K112056ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL2Cleared 510(K)
- K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS2Cleared 510(K)
- K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS2Cleared 510(K)
- K111111ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO2Cleared 510(K)
- K110728IMESH TACKER2Cleared 510(K)
- K111153SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM2Cleared 510(K)
- K111064TIGERPAW SYSTEM II2Cleared 510(K)
- K103672REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET2Cleared 510(K)
- K110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER2Cleared 510(K)
- K110049REUSABLE LINEAR STAPLER HANDLE2Cleared 510(K)
- K103470PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP2Cleared 510(K)
- K103263ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY2Cleared 510(K)
- K101961TIGERPAW SYSTEM2Cleared 510(K)
- K102325IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)2Cleared 510(K)
- K102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER2Cleared 510(K)
- K102291COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K101378FRANKENMAN SURGICAL STAPLERS2Cleared 510(K)
- K101444AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K100723DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.52Cleared 510(K)
- K093845ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP252Cleared 510(K)
- K100386DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 322Cleared 510(K)
- K092483BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 01160182Cleared 510(K)
- K093402AUTOSUTURE EEA ORVIL2Cleared 510(K)
- K093410AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K093253AMID STAPLER2Cleared 510(K)
- K092577ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)2Cleared 510(K)
- K091900ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE2Cleared 510(K)
- K090821CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L2Cleared 510(K)
- K091322CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G2Cleared 510(K)
- K091215INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT2Cleared 510(K)
- K083519AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS2Cleared 510(K)
- K090159INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES2Cleared 510(K)
- K083781EEA HEMORRHOID STAPLER & ACCESSORIES2Cleared 510(K)
- K082396DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 01130872Cleared 510(K)
- K083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS2Cleared 510(K)
- K071023REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C2Cleared 510(K)
- K081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V2Cleared 510(K)
- K080972ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP2Cleared 510(K)
- K081146ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)2Cleared 510(K)
- K080839ECHELON GRAY CARTRIDGE, MODEL ERC45M2Cleared 510(K)
- K080898AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT2Cleared 510(K)
- K073001IDRIVES, IDRIVEC, IDRIVEF2Cleared 510(K)
- K073148IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS2Cleared 510(K)
- K071920AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2Cleared 510(K)
- K071708I45, I45S, I60, AND I60S2Cleared 510(K)
- K070887ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)2Cleared 510(K)
- K071061ABSORBATACK AND APPLICATOR2Cleared 510(K)
- K062869CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G2Cleared 510(K)
- K063746POWER EXTENDERS MODEL# PEC200, PES200,PES200S2Cleared 510(K)
- K063075NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS2Cleared 510(K)
- K062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2Cleared 510(K)
- K061649POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH2Cleared 510(K)
- K061784INSORB ABSORBABLE STAPLE, MODEL 10202Cleared 510(K)
- K061156ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS2Cleared 510(K)
- K060494EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM2Cleared 510(K)
- K061095AUTO SUTUR ENDO GIA STAPLERS2Cleared 510(K)
- K053631CONTOUR TRANSTAR CURVED CUTTER STAPLER SET2Cleared 510(K)
- K052910POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS2Cleared 510(K)
- K052415POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS2Cleared 510(K)
- K051301PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES2Cleared 510(K)
- K051848SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 01130792Cleared 510(K)
- K050610SALUTE FIXATION SYSTEM2Cleared 510(K)
- K051002ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER2Cleared 510(K)
- K042492HAND STC, MODEL 60MM2Cleared 510(K)
- K041159JMS ABSORBABLE ANCHOR AND APPLICATOR2Cleared 510(K)
- K041331BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER2Cleared 510(K)
- K041201ULTRACLIP II MR2Cleared 510(K)
- K040720SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM2Cleared 510(K)
- K040109HEMORRHAGE OCCLUDER PIN2Cleared 510(K)
- K040398SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS2Cleared 510(K)
- K040038CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G2Cleared 510(K)
- K040024SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS292Cleared 510(K)
- K032973REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS2Cleared 510(K)
- K033602INSORB ABSORBABLE STAPLE, MODEL SP-B202Cleared 510(K)
- K032696AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT2Cleared 510(K)
- K032701SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)2Cleared 510(K)
- K032347BIOMARC TISSUE MARKER2Cleared 510(K)
- K030925PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH012Cleared 510(K)
- K024117INSORB ABSORBABLE STAPLES, MODEL SP-B202Cleared 510(K)
- K030653SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS2Cleared 510(K)
- K030411PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH032Cleared 510(K)
- K024275AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER2Cleared 510(K)
- K023725HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-2472Cleared 510(K)
- K022313SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V2Cleared 510(K)
- K020804AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER2Cleared 510(K)
- K021701SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC602Cleared 510(K)
- K020779PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS2Cleared 510(K)
- K021249SURGASSIST FLEXSHAFT 2, MODEL FS2 142Cleared 510(K)
- K020719SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES2Cleared 510(K)
- K020343SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL2Cleared 510(K)
- K014286SALUTE, MODEL 30222Cleared 510(K)
- K013749ENDOANCHOR AND OPENANCHOR2Cleared 510(K)
- K013860AUTO SUTURE SURGICAL STAPLES2Cleared 510(K)
- K012809SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC452Cleared 510(K)
- K012362MODIFICATION TO VASCULAR CLOSURE DEVICE2Cleared 510(K)
- K001807TISSUE MARKER2Cleared 510(K)
- K003522SALUTE2Cleared 510(K)
- K003277SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS332Cleared 510(K)
- K003169VASCULAR CLOSURE DEVICE2Cleared 510(K)
- K001895AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER2Cleared 510(K)
- K000060GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK00072Cleared 510(K)
- K000608SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM2Cleared 510(K)
- K993785ULTRACLIP TISSUE MARKER2Cleared 510(K)
- K991030PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES2Cleared 510(K)
- K983318FIXATION SYSTEM2Cleared 510(K)
- K983400AUTO SUTURE SITE MARKER CLIP2Cleared 510(K)
- K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS2Cleared 510(K)
- K980617MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER2Cleared 510(K)
- K970817MICROMARK CLIP2Cleared 510(K)
- K963015SURGICAL STAPLE MARKER DEVICE (MODIFY)2Cleared 510(K)
- K952239AUTO SUTURE* MODIFIED LINEAR STAPLER**2Cleared 510(K)
- K950006SURGICAL STAPLE MARKER2Cleared 510(K)
- K942606SURGICAL STAPLE2Cleared 510(K)
- K931103STRYKER STAPLER SYSTEM2Cleared 510(K)
- K931056DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING2Cleared 510(K)
- K922186HEM-O-LOK -- MODIFICATION2Cleared 510(K)
- K920752ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER2Cleared 510(K)
- K9210513M PRECISE BRAND INTERNAL SURGICAL STAPLES2Cleared 510(K)
- K915693PROXIMATE ABSORBABLE STAPLES2Cleared 510(K)
- K915489AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE2Cleared 510(K)
- K914130AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES2Cleared 510(K)
- K913802AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER2Cleared 510(K)
- K913832AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER2Cleared 510(K)
- K913211AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER2Cleared 510(K)
- K913411DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING2Cleared 510(K)
- K913139IMPLANTABLE METAL STAPLES2Cleared 510(K)
- K911252PRECISE BARND PI DISPOSABLE SURGICAL STAPLES2Cleared 510(K)
- K910897PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X2Cleared 510(K)
- K910192AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER2Cleared 510(K)
- K905106AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER2Cleared 510(K)
- K900129MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*2Cleared 510(K)
- K900055MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS2Cleared 510(K)
- K900043MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER2Cleared 510(K)
- K892233AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER2Cleared 510(K)
- K890841TITANIUM STAPLES2Cleared 510(K)
- K890270AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*2Cleared 510(K)
- K890447HEMORRHAGE OCCLUDOR2Cleared 510(K)
- K885222PRECISE ILA AND ILAN SURGICAL STAPLES2Cleared 510(K)
- K881484BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING2Cleared 510(K)
- K873748RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT2Cleared 510(K)
- K864146DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)2Cleared 510(K)
- K855047AUTO SUTURE TITANIUM SURGICAL STAPLES2Cleared 510(K)
- K851122PI-PNEUMO INTESTINAL STAPLING CARTRIDGE2Cleared 510(K)
- K843399SURGEONS CHOICE PI VASCULAR STAPLING2Cleared 510(K)
- K843603AUTO SUTURE POLY GIA SURGICAL STAPLER2Cleared 510(K)
- K843034DISPOSABLE LINEAR CUTTER2Cleared 510(K)
- K833698AMER. V. MUELLER SURG. STAPLES ILA2Cleared 510(K)
- K833704AMER. V. MUELLER SURGICALSTAPLES-CARTR2Cleared 510(K)
- K823552APPOSE SKIN STAPLER & REMOVER2Cleared 510(K)
- K830199AUTO SUTURE TA DISPOS-STAPLE CART2Cleared 510(K)
- K822345DISPOSABLE LINEAR STAPLER (LSF)2Cleared 510(K)
- K821994DISPOSABLE LINEAR STAPLER-(LSR)2Cleared 510(K)
- K810324AUTOMATIC HEMOCLIP APPLIER, 5277002Cleared 510(K)
- K801154PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.2Cleared 510(K)
- K780695AUTO SUTURE DISPOSABLE STAPLING INSTRU.2Cleared 510(K)
- K780586MICROCLIP, WILLIAMS2Cleared 510(K)
- K771178DISP. LOADING UNIT, AUTO, SUTURE2Cleared 510(K)
- K761064COVENTRY STAPLE2Cleared 510(K)
- 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
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- GEYMotor, Surgical Instrument, Ac-Powered1Product Code
- GFABlade, Saw, General & Plastic Surgery, Surgical1Product Code
- GFBHead, Surgical, Hammer1Product Code
- GFCDriver, Surgical, Pin1Product Code
- GFDDermatome1Product Code
- GFEBrush, Dermabrasion, Powered1Product Code
- GFFBur, Surgical, General & Plastic Surgery1Product Code
- GFGBit, Surgical1Product Code
- GFIOsteotome, Manual1Product Code
- GFJMallet, Surgical, General & Plastic Surgery1Product Code
- HABSaw, Powered, And Accessories1Product Code
- HAMApparatus, Electrosurgical2Product Code
- HBIIlluminator, Fiberoptic, Surgical Field2Product Code
- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- 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
- 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
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K142873
- 510(k) Type
- Traditional
- Applicant
- C.R.Bard Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/12/2015
- Days to Decision
- 162 days
- Submission Type
- Summary