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
- K241376HyperSuture All Blue Extension Line2Cleared 510(K)
- K234079HyperSuture Extension Line2Cleared 510(K)
- K231163HS Fiber Sutures2Cleared 510(K)
- K230311HyperSuture2Cleared 510(K)
- K231183Non absorbable Surgical Polyester Suture2Cleared 510(K)
- K223500SuperBall Meniscal Repair System2Cleared 510(K)
- K223122MENIX®; MENIX® DUO2Cleared 510(K)
- K230510MyEllevate2Cleared 510(K)
- K213046AceConnex Pre-Sutured Fascia2Cleared 510(K)
- K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )2Cleared 510(K)
- K223822ACTIVBRAID™2Cleared 510(K)
- K220880Arthrex BioSuture2Cleared 510(K)
- K222078Arthrex SoftStitch2Cleared 510(K)
- K221354Arthrex SutureTape2Cleared 510(K)
- K220186Zone Specific AIM2Cleared 510(K)
- K220219PERMALOOP Suture, PERMATAPE Suture2Cleared 510(K)
- K212146Arthrex LoopLoc Knotless Suture2Cleared 510(K)
- K210675EasyWhip2Cleared 510(K)
- K203186DYNATAPE Suture2Cleared 510(K)
- K203393FAST-FIX FLEX2Cleared 510(K)
- K190707Arthrex SoftStitch2Cleared 510(K)
- K202242HS Fiber2Cleared 510(K)
- K193575Arthrex SutureTape2Cleared 510(K)
- K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch2Cleared 510(K)
- K192637High Strength Suture2Cleared 510(K)
- K190777DemeTECH DemeFORCE Nonabsorbable Surgical Suture2Cleared 510(K)
- K191268Force Fiber Suture2Cleared 510(K)
- K190817HS Fiber2Cleared 510(K)
- K181633MTF Pre-Sutured Tendon2Cleared 510(K)
- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture2Cleared 510(K)
- K181182DYNACORD Suture2Cleared 510(K)
- K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)2Cleared 510(K)
- K180191SuperBall Meniscal Repair System2Cleared 510(K)
- K180531NovoStitch Pro Meniscal Repair System2Cleared 510(K)
- K170957ReConnex Pre-Sutured Tendon2Cleared 510(K)
- K172016Force Fiber Fusion Suture2Cleared 510(K)
- K170642GRAVITY™ Soft Tissue Repair System2Cleared 510(K)
- K171680Infinity-Lock 3, Infinity-Lock 52Cleared 510(K)
- K171296SutureTape2Cleared 510(K)
- K163651ExpressBraid Graft Manipulation2Cleared 510(K)
- K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader2Cleared 510(K)
- K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture2Cleared 510(K)
- K162247PERMATAPE2Cleared 510(K)
- K162310XBraid TT Suture Tape2Cleared 510(K)
- K161638SPEEDTRAP Graft Preparation System2Cleared 510(K)
- K153089'cottony' II TAPE, PLEDGETS2Cleared 510(K)
- K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved2Cleared 510(K)
- K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL2Cleared 510(K)
- K153746Dunamis Force DFX Tensile Tape2Cleared 510(K)
- K153307HS SutureTape2Cleared 510(K)
- K152868ExpressBraid Graft Manipulation2Cleared 510(K)
- K153096LARIAT RS Suture Delivery Device2Cleared 510(K)
- K151758ALAR Nasal Valve Stent2Cleared 510(K)
- K151009Nexus Suture2Cleared 510(K)
- K150584Stryker Suture Tape2Cleared 510(K)
- K143356NovoStitch Plus Meniscal Repair System2Cleared 510(K)
- K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 22Cleared 510(K)
- K150438Force Fiber OrthoTape suture2Cleared 510(K)
- K142241LARIAT sulture Delivery Device2Cleared 510(K)
- K141072SUPOLENE2Cleared 510(K)
- K133770A.I.M. KNOTLESS MENISCAL REPAIR DEVICE2Cleared 510(K)
- K140019ARTHREX BIOSUTURE2Cleared 510(K)
- K132079TFCC FAST-FIX KIT2Cleared 510(K)
- K132357SMITH & NEPHEW ULTRATAPE2Cleared 510(K)
- K132043ARTHREX SPEEDCINCH2Cleared 510(K)
- K122735SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS22Cleared 510(K)
- K123268SMARTSTITCH PERFECTPASSER SYSTEM2Cleared 510(K)
- K121861SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N2Cleared 510(K)
- K122374ARTHREX SUTURE (UHMWPE)2Cleared 510(K)
- K121306SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE2Cleared 510(K)
- K121413CROSSFIX II MEMISCAL REPAIR DEVICE2Cleared 510(K)
- K112899ARTHREX BIO-SUTURE2Cleared 510(K)
- K101377SMITH & NEWPHEW ULTRABRAID II SUTURE2Cleared 510(K)
- K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE2Cleared 510(K)
- K103052V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE2Cleared 510(K)
- K102916G-CATH TISSUE ANCHOR DELIVERY CATHETER2Cleared 510(K)
- K102028NEOTRACT ANCHOR SYSTEM MODEL TAS4002Cleared 510(K)
- K101252NEOTRACT ANCHOR SYSTEM MODEL: REF 112082Cleared 510(K)
- K100006HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED2Cleared 510(K)
- K094028CP-FIBER (ORTHOFIBER)2Cleared 510(K)
- K100572VERSACLOSE, MODEL VC-200-012Cleared 510(K)
- K100506FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK2Cleared 510(K)
- K100251G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 2053332Cleared 510(K)
- K092508FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,2Cleared 510(K)
- K091061IMPLICITGUIDE SURGICAL SUTURE SYSTEM2Cleared 510(K)
- K091574SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES2Cleared 510(K)
- K093018G-PROX ENDOSCOPIC GRASPER, MODEL 2053332Cleared 510(K)
- K092533FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES2Cleared 510(K)
- K091432XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-012Cleared 510(K)
- K090385LARIAT II SUTURE DELIVERY DEVICE2Cleared 510(K)
- K091016COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE2Cleared 510(K)
- K090128TAC-TITE (TM)2Cleared 510(K)
- K082518DUAL NEEDLE SUTURE PASSER SYSTEM2Cleared 510(K)
- K082535COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE2Cleared 510(K)
- K073149MENISCAL CINCH2Cleared 510(K)
- K073096ANCHORAGE CLOSURE DEVICE2Cleared 510(K)
- K073651NEOTRACT ANCHOR SYSTEM2Cleared 510(K)
- K071796CAPSEW PLICATION SYSTEM2Cleared 510(K)
- K072322ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS2Cleared 510(K)
- K070253AXYA SUTURE WELDING SYSTEM AND KIT2Cleared 510(K)
- K071622ARTHREX FIBERWIRE2Cleared 510(K)
- K070673FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE2Cleared 510(K)
- K063778FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE2Cleared 510(K)
- K061276G-PROX ENDOSCOPIC GRASPER2Cleared 510(K)
- K063194TUFFLEX POLYESTER SUTURE2Cleared 510(K)
- K060163CARDIOFLON, CARDIOXYL2Cleared 510(K)
- K062307XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS2Cleared 510(K)
- K060165AXYAFLEX POLYESTER SUTURE2Cleared 510(K)
- K060367TENOLIG2Cleared 510(K)
- K061386ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB2Cleared 510(K)
- K060721LARIAT LOOP APPLICATOR2Cleared 510(K)
- K053339ALLOFIX ANCHOR2Cleared 510(K)
- K050150MANI NEEDLE & SUTURE PACK2Cleared 510(K)
- K052652SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE2Cleared 510(K)
- K041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE2Cleared 510(K)
- K042038MTF ALLOGRAFT ANCHOR2Cleared 510(K)
- K041553ARTHREX SUTURE GRAFTING KIT2Cleared 510(K)
- K042286UNIESTER C2Cleared 510(K)
- K042031OPUS SPEEDSTITCH SUTURE DEVICE2Cleared 510(K)
- K041894ORTHOFIBER2Cleared 510(K)
- K041589ARTHREX FIBERWIRE WITH SILK2Cleared 510(K)
- K041216SMITH & NEPHEW ULTRABRAID SUTURE2Cleared 510(K)
- K040789DURABRAID SUTURE2Cleared 510(K)
- K040472FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE2Cleared 510(K)
- K040232LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 0209992Cleared 510(K)
- K033718MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE2Cleared 510(K)
- K033654FORCE FIBER2Cleared 510(K)
- K032245ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-72392Cleared 510(K)
- K032901STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM2Cleared 510(K)
- K023030DEMETECH POLYESTER NONABSORBABLE SUTURE2Cleared 510(K)
- K021434ARTHREX FIBERWIRE IN USP SIZES2Cleared 510(K)
- K022410SAPH-LOOP LIGATING LOOP2Cleared 510(K)
- K021019COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE2Cleared 510(K)
- K020902SERRALESTER2Cleared 510(K)
- K013990LIFESTITCH SUTURING DEVICE2Cleared 510(K)
- K012923ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-72012Cleared 510(K)
- K012201PREMICRON NONABSORBABLE PET SURGICAL SUTURE2Cleared 510(K)
- K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)2Cleared 510(K)
- K010673ARTHREX FIBERWIRE, MODEL SPU-02NB-38002Cleared 510(K)
- K003590GRAMS POLYESTER NONABSORBABLE SUTURE2Cleared 510(K)
- K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTURE2Cleared 510(K)
- K001172POLYESTER NONABSORBABLE SURGICAL SUTURES URP2Cleared 510(K)
- K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE2Cleared 510(K)
- K000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USP2Cleared 510(K)
- K994000POLYESTER2Cleared 510(K)
- N16374PRONOVA ABSORABLE SUTURE, USP2PMA Approval
- K990952NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES2Cleared 510(K)
- K984550PRE-THREADED ENDOBUTTON2Cleared 510(K)
- K990088SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE2Cleared 510(K)
- K972911AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER2Cleared 510(K)
- K980155ENDOBUTTON CONTINUOUS LOOP2Cleared 510(K)
- K970416ACUFEX DOUBLE ARMED SUTURE NEEDLE2Cleared 510(K)
- K961925POLYESTER NONABSORBABLE SURGICAL SUTURES USP2Cleared 510(K)
- K961025EXPANDED BODY SUTURE2Cleared 510(K)
- K955747USSC NONABSORBABLE SUTURES2Cleared 510(K)
- K952535ACUFEX ENDOBUTTON TAPE2Cleared 510(K)
- K943221SURGIBOND2Cleared 510(K)
- K943220SUTULENE2Cleared 510(K)
- K943949POLYVIOLENE SURGICL SUTURE2Cleared 510(K)
- K931916SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER2Cleared 510(K)
- K932038SUTURE NONABSORBABLE- SILK, POLYESTER2Cleared 510(K)
- K930945BRAIDED POLYESTER SURGICAL SUTURE2Cleared 510(K)
- K930942LUKENS SILK SURGICAL SUTURE2Cleared 510(K)
- K930590SILK SUTURES2Cleared 510(K)
- K930591TI-CRON AND DACRON SUTURES2Cleared 510(K)
- K926167POLYVIOLENE SUTURE-REVISED LABELING2Cleared 510(K)
- K920421MEDSURG MARSHMALLOW TRAY2Cleared 510(K)
- P810028DEKLENE(TM)2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N17825SURGILENE2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N17825SURGILENE2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N17825SURGILENE2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N17825SURGILENE2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N17825SURGILENE2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N17825SURGILENE2PMA Approval
- P810028DEKLENE(TM)2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N17825SURGILENE2PMA Approval
- N17825SURGILENE2PMA Approval
- N17825SURGILENE2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE POLYPROPYLENE NONAB.SURG. SUTURE2PMA Approval
- N17825SURGILENE POLYPROPYLEME NONABSORBABLESUTURES2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- N17825SURGILENE2PMA Approval
- N16374PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S2PMA Approval
- 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
- 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
FAST-FIX FLEX
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K203393
- 510(k) Type
- Traditional
- Applicant
- Smith & Nephew, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/1/2021
- Days to Decision
- 75 days
- Submission Type
- Summary