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
- K253903InnoClip Disposable Clip Applier2Cleared 510(K)
- K253781InnoClip Clip Applier2Cleared 510(K)
- K250643Disposable Polymer Ligation Clips2Cleared 510(K)
- K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips2Cleared 510(K)
- K242541GEM ZIPCLIP2Cleared 510(K)
- K221495SOLID CLIP™ Single Use Clip Applier2Cleared 510(K)
- K232970Hem-o-lok® Ligating Clips2Cleared 510(K)
- K230966angiOCCLUDE Ligating Clips2Cleared 510(K)
- K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)2Cleared 510(K)
- K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)2Cleared 510(K)
- K213813DuraFuse Clip and Applier System2Cleared 510(K)
- K220006angioLOCK Polymer Ligating Clip2Cleared 510(K)
- K202994InnoClip Disposable Clip Applier, InnoClip Clip Applier2Cleared 510(K)
- K200166Mirus Ligating Clip, Mirus Ligating Clip Applier2Cleared 510(K)
- K202124Aesculap PAS-Port Proximal Anastomosis System2Cleared 510(K)
- K192711Dannik Titanium Ligation Clip2Cleared 510(K)
- K180650Amsel Endo Occluder2Cleared 510(K)
- K181488LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier2Cleared 510(K)
- K173323AnastoClip GC Closure System2Cleared 510(K)
- K180010AtriClip FLEX-V2Cleared 510(K)
- K173031AtriClip LAA Exclusion System with Preloaded PRO·V Clip2Cleared 510(K)
- K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)2Cleared 510(K)
- K172479Amsel Occluder Device2Cleared 510(K)
- K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip2Cleared 510(K)
- K161758Weck Auto Endo10 Automatic Endoscopic Clip Applier2Cleared 510(K)
- K151943Vas-Q-Clip2Cleared 510(K)
- K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip2Cleared 510(K)
- K152082Vesocclude Polymer Ligating Clip2Cleared 510(K)
- K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip2Cleared 510(K)
- K150259CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L2Cleared 510(K)
- K150936SureClip2Cleared 510(K)
- K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿2Cleared 510(K)
- K150840Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier2Cleared 510(K)
- K152081Weck Auto Endo5 Hem-o-lok Ligating Clip Applier2Cleared 510(K)
- K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip2Cleared 510(K)
- K143598Lapro-Clip Auto Suture Reusable Long Clip Applier2Cleared 510(K)
- K140932AMSEL OCCLUDER DEVICE2Cleared 510(K)
- K142777Weck Hem-o-lok Auto Endo5 Ligating Clip Applier2Cleared 510(K)
- K142869Premium Surgiclip III2Cleared 510(K)
- K142120ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP2Cleared 510(K)
- K133202HEM-O-LOK LIGATING CLIP2Cleared 510(K)
- K132658HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS2Cleared 510(K)
- K131107ATRICLIP GILLINOV-COSGROVE LAA CLIP2Cleared 510(K)
- K122276ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP2Cleared 510(K)
- K121194ENDO CLIP III 5MM CLIP APPLIER2Cleared 510(K)
- K111930ACKERMANN EUROPCLIP2Cleared 510(K)
- K110699LIGAMAX 52Cleared 510(K)
- K093661COLONRING2Cleared 510(K)
- K102081ENDOSCOPIC CLIP SYSTEM2Cleared 510(K)
- K101018CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-0001002Cleared 510(K)
- K093679ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA02Cleared 510(K)
- K091987ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP2Cleared 510(K)
- K100242AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER2Cleared 510(K)
- K100090IMPLANTABLE CLIP2Cleared 510(K)
- K091060VESOCCLUDE LIGATING CLIP2Cleared 510(K)
- K091017CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-0000012Cleared 510(K)
- K090872MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM2Cleared 510(K)
- K081225CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM2Cleared 510(K)
- K081082U-CLIP UNI-FIRE, MODEL M652Cleared 510(K)
- K081031ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE2Cleared 510(K)
- K080753AESCULAP ENDOSCOPIC CLIP SYTEM2Cleared 510(K)
- K073304CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES2Cleared 510(K)
- K073123CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-0001502Cleared 510(K)
- K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2Cleared 510(K)
- K072525ZIPKNOT, MODEL 1017-30002Cleared 510(K)
- K070548C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM2Cleared 510(K)
- K063644CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM2Cleared 510(K)
- K062821U-CLIP DEVICE2Cleared 510(K)
- K053524C-PORT DISTAL ANASTOMOSIS SYSTEM2Cleared 510(K)
- K062914HEM-O-LOK LIGATION CLIP2Cleared 510(K)
- K061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2Cleared 510(K)
- K062008ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)2Cleared 510(K)
- K062057U-CLIP DEVICE, MODEL NC652Cleared 510(K)
- K053255NEXUS LIGATING CLIP2Cleared 510(K)
- K053252U-CLIP DEVICE, MODELS B140, B160 AND B1802Cleared 510(K)
- K040832C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-0000502Cleared 510(K)
- K052018MILTEX LIGATING CLIP2Cleared 510(K)
- K051125IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 146772Cleared 510(K)
- K050356COMPRESSION ANASTOMOSIS RING (CAR)2Cleared 510(K)
- K050344LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER2Cleared 510(K)
- K043115LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)2Cleared 510(K)
- K041751COMPRESSION ANASTOMOSIS CLIP (CAC)2Cleared 510(K)
- K040602SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS2Cleared 510(K)
- K033324COMPRESSION ANASTOMOSIS CLIP (CAC)2Cleared 510(K)
- K040821COALESCENT SURGICAL U-CLIP AND ACCESSORIES2Cleared 510(K)
- K033979CORLINK AUTOMATED ANASTOMOTIC SYSTEM2Cleared 510(K)
- K032896ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-022Cleared 510(K)
- K033161VISU-LOCK 5MM CLIP APPLIER2Cleared 510(K)
- K032980AMI REPROCESSED MULTIPLE CLIP APPLIERS2Cleared 510(K)
- K033024MODIFICATION TO SUTURE CLINCH2Cleared 510(K)
- K032238TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER2Cleared 510(K)
- K03221714G CORMARK BIOPSY SITE IDENTIFIER2Cleared 510(K)
- K030926FAST THROW STAINLESS STEEL SURGICAL SUTURE2Cleared 510(K)
- K031623MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES2Cleared 510(K)
- K030269GENICON CLIP APPLIER2Cleared 510(K)
- K030311HEM-O-LOK XL CLIP2Cleared 510(K)
- K024366COALESCENT SURGICAL U-CLIP AND ACCESSORIES2Cleared 510(K)
- K020054SANARUS INDICA MARKER SYSTEM2Cleared 510(K)
- K020879IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 10012Cleared 510(K)
- K021808WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER2Cleared 510(K)
- K021407COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES2Cleared 510(K)
- K020470MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE2Cleared 510(K)
- K013264MICRO STAMPING LIGATING CLIP2Cleared 510(K)
- K012342AMS SOFT-TISSUE APPROXIMATION SYSTEM2Cleared 510(K)
- K012317COALESCENT SURGICAL U-CLIP2Cleared 510(K)
- K011402BIOPSY SITE MARKER2Cleared 510(K)
- K011236MODIFICATION TO IMPLANTABLE CLIP2Cleared 510(K)
- K003777CARIS SITE MARKER2Cleared 510(K)
- K003958COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE2Cleared 510(K)
- K003337HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 5442402Cleared 510(K)
- K001450AUTO SUTURE MICRO SURGICLIP CLIP APPLIER2Cleared 510(K)
- K000278VIVANT MEDICAL BIOPSY MARKER SYSTEM2Cleared 510(K)
- K994160COALESCENT SURGICAL SUTURED-CLIP2Cleared 510(K)
- K993424THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP2Cleared 510(K)
- K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 5442402Cleared 510(K)
- K993135IMPLANTABLE CLIP FOR GENERAL SURGERY2Cleared 510(K)
- K991002PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP2Cleared 510(K)
- K984438MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE2Cleared 510(K)
- K982944HEM-O-LOCK, MODEL 5239352Cleared 510(K)
- K982941HEM-O-LOK MODEL NUMBERS 523900, 5239702Cleared 510(K)
- K981645TITANIUM HEMOSTATIC CLIP2Cleared 510(K)
- K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS2Cleared 510(K)
- K981631INFLUENCE CLIP SYSTEM2Cleared 510(K)
- K981239DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS2Cleared 510(K)
- K973652DUOCLIPPER TITANIUM CLIPS2Cleared 510(K)
- K971588EVI SUTURED-CLIP APPLIER2Cleared 510(K)
- K970793IMPLANTABLE CLIP2Cleared 510(K)
- K971201AUTO SUTURE* ILM** KIT2Cleared 510(K)
- K964470APPLIED MEDICAL CLIP APPLIER2Cleared 510(K)
- K964109MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP2Cleared 510(K)
- K962043AUTO SUTURE MODIFIED VCS CLIP APPLIER2Cleared 510(K)
- K962016MEDLINE TITANIUM HEMOCLIPS2Cleared 510(K)
- K953258TITANIUM HEMOSTATIC CLIP2Cleared 510(K)
- K953908DAVIS & GECK LIGATING CLIP REMOVER2Cleared 510(K)
- K954435WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES2Cleared 510(K)
- K950540IMPLANTABLE CLIP2Cleared 510(K)
- K945231SELF-LATCHING CLIP2Cleared 510(K)
- K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP2Cleared 510(K)
- K943159LIFE CLIP AND LIFE CLIP APPLIER2Cleared 510(K)
- K941972HEMO-O-LOK2Cleared 510(K)
- K934087IMPLANTABLE CLIP APPLIER2Cleared 510(K)
- K933887IMPLANTABLE CLIP2Cleared 510(K)
- K931492LAPRA-TY* SUTURE CLIP2Cleared 510(K)
- K920847ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER2Cleared 510(K)
- K915151AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE2Cleared 510(K)
- K911915HEMOCLIP II2Cleared 510(K)
- K905587AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE2Cleared 510(K)
- K902108HEM-O-LOK(TM)2Cleared 510(K)
- K900122AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP*2Cleared 510(K)
- K896997ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)2Cleared 510(K)
- K883018AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER2Cleared 510(K)
- K873309REFLEX(TM) CA-T CLIP APPLIER2Cleared 510(K)
- K864350VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER2Cleared 510(K)
- K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIER2Cleared 510(K)
- K862404REFLEX(TM) CLIP APPLIER2Cleared 510(K)
- K861922TITANIUM HEMOSTATIC CLIPS2Cleared 510(K)
- K861471V. MUELLER VITAL CLIP-HEMOSTATIC CLIP2Cleared 510(K)
- K853650AUTO SUTURE TITANIUM HEMOSTATIC CLIP2Cleared 510(K)
- K851251AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 5272002Cleared 510(K)
- K850273ETHICON - CHOLANGIOCLIP2Cleared 510(K)
- K843336AUTOMATIC MULTICLIP DISPOS. LIGATING2Cleared 510(K)
- K843589TICLIP STERIAL DISPOSABLE2Cleared 510(K)
- K841547HEMOCLIP LIGATING CLIPS MED/SML2Cleared 510(K)
- K841549HEMOCLIP AUTOMATIC CLIPS MEDIUM2Cleared 510(K)
- K841548HEMOCLIP LIGATING CLIPS M/LARGE2Cleared 510(K)
- K8423823M RAPIDSTAT LIGATING CLIP SYS2Cleared 510(K)
- K834267LIGACLIP METALLIC LIGATING CLIP2Cleared 510(K)
- K831457AUTO SUTURE POLY SURGICLIP HEMOSTATIC2Cleared 510(K)
- K830503LIGACLIP TITANIUM LIGATING CLIP2Cleared 510(K)
- K820999MULTICLIP DISP. LIGATING CLIP DEVICE2Cleared 510(K)
- K812323PDS* ABSORBABLE LIGATING CLIPS2Cleared 510(K)
- K811935PROLENE POLYPROPYLENE LIGATING CLIP2Cleared 510(K)
- K801124NYLON LIGATING CLIP2Cleared 510(K)
- K800079HEMOCLIP SURGICAL OCCLUDING CLIP2Cleared 510(K)
- K771413LIGACLIP MULTIPLE LIGATING CLIPS2Cleared 510(K)
- K771112AUTO SUTURE R CLIP2Cleared 510(K)
- 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
- 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
- SFGCamera, Surgical, Measurement1Product Code
- SGVAgent, Absorbable Hemostatic, Collagen With Polymeric Additives3Product 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
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K003337
- 510(k) Type
- Traditional
- Applicant
- Weck Closure Systems
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/2000
- Days to Decision
- 57 days
- Submission Type
- Summary