Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- K220036Wellead Ureteral Catheter2Cleared 510(K)
- K220730allFlex Ureteral Catheters, Krait Ureteral Catheters2Cleared 510(K)
- K211032Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2Cleared 510(K)
- K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2Cleared 510(K)
- K180354UroGen Ureteral Catheter2Cleared 510(K)
- K181144Angled Tip Ureteral Catheter2Cleared 510(K)
- K180530Imager II Urology Torque Catheter2Cleared 510(K)
- K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter2Cleared 510(K)
- K171600Renal Access Cobra Catheter, Kumpe Access Catheter2Cleared 510(K)
- K171662Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter2Cleared 510(K)
- K172924GentleCath Intermittent Urinary Catheter2Cleared 510(K)
- K161344GentleCath Glide Intermittent Catheter2Cleared 510(K)
- K160877United Urologics Closed System Catheter2Cleared 510(K)
- K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER2Cleared 510(K)
- K110491BACKSTOP CATHETER2Cleared 510(K)
- K103349BACKSTOP CATHETER2Cleared 510(K)
- K102527IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER2Cleared 510(K)
- K090270BACKSTOP CATHETER, MODEL 60-0000-31002Cleared 510(K)
- K080878MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)2Cleared 510(K)
- K080881CURE CATHETER CLOSED SYSTEM2Cleared 510(K)
- K040897DOVER ROB-NEL CATHETER2Cleared 510(K)
- K041243DOVER RED RUBBER ROBINSON CATHETER2Cleared 510(K)
- K033719BARD TIGERTAIL URETERAL CATHETER2Cleared 510(K)
- K032710CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT2Cleared 510(K)
- K033023INTERMITTENT URETHRAL CATHETERS2Cleared 510(K)
- K022135URETERAL ACCESS SHEATH SET (UASS)2Cleared 510(K)
- K013483INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT2Cleared 510(K)
- K013345INCARE INTERMITTENT CATHETER2Cleared 510(K)
- K011965IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X12Cleared 510(K)
- K010339ENDOCARE PERCUTANEOUS ACCESS SET2Cleared 510(K)
- K002396ENDOCARE PERCUTANEOUS ACCESS SET2Cleared 510(K)
- K001583ISLAND BIOSURGICAL BNS KIT #32Cleared 510(K)
- K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)2Cleared 510(K)
- K000070FLOCATH2Cleared 510(K)
- K965229IMAGER TORQUE CATHETER2Cleared 510(K)
- K951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT2Cleared 510(K)
- K945061NOPROFILE OLBERT CATHETER SYSTEM2Cleared 510(K)
- K922527BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY2Cleared 510(K)
- K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYS2Cleared 510(K)
- K915459FLOWMATE HAND PUMP2Cleared 510(K)
- K931195PERCUTANEOUS DRAINAGE LOOP CATHETER SET2Cleared 510(K)
- K933400KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR2Cleared 510(K)
- K930608ONIK-COHEN ACCESS SET2Cleared 510(K)
- K923906FOLEY INSERTION TRAY2Cleared 510(K)
- K922051KIT PAK'S FLUSHING KIT2Cleared 510(K)
- K922431BARD LATEX URINARY CATHETERS2Cleared 510(K)
- K923607RADIFOCUS GUIDE WIRE M2Cleared 510(K)
- K921054KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.2Cleared 510(K)
- K921415IRRIGATION TUBING SET2Cleared 510(K)
- K921253INSTRUMENT IRRIGATION PUMP2Cleared 510(K)
- K914933HEART PACK III2Cleared 510(K)
- K912851NAUDE URETHRAL STENT2Cleared 510(K)
- K911242KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER2Cleared 510(K)
- K900509NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH2Cleared 510(K)
- K904734PHARMASEAL DISPOSABLE ABDOMINAL TROCAR2Cleared 510(K)
- K896729NELATON-, FEMALE - OR TIEMANN CATHETER2Cleared 510(K)
- K896750LOFRIC(R), LOFRIC(R) CATH-KIT2Cleared 510(K)
- K901738SELFCATH2Cleared 510(K)
- K900229BARD CONFORMACATH FOLEY CATHETER2Cleared 510(K)
- K900022BJ STAR ALL SILICONE FOLEY BALLOON CATHETER2Cleared 510(K)
- K8967264 SURE EXTERNAL MALE CATHETER2Cleared 510(K)
- K896784DISPOSABLE URODYNAMIC CATHETER SET2Cleared 510(K)
- K8967254 SURE UROLOGICAL CATHETER2Cleared 510(K)
- K896053ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K895548CONVEEN INTERMITTENT CATHETERS2Cleared 510(K)
- K896385URETERAL ACCESS SET2Cleared 510(K)
- K896213Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET2Cleared 510(K)
- K896211CYSTOSCOPY/IRRIGATION SET2Cleared 510(K)
- K896208CYSTO PUMP DRAINAGE BAG2Cleared 510(K)
- K890400MODIFIED URINARY CATHETER INTRODUCER (UCI)2Cleared 510(K)
- K893390MODIFIED PRISTINE CULTURE CATHETER2Cleared 510(K)
- K892436KENDALL CURITY IRRIGATION SYRINGE2Cleared 510(K)
- K892691CATHETERS, MALE, FEMALE2Cleared 510(K)
- K88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR2Cleared 510(K)
- K883763ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH2Cleared 510(K)
- K881981ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM2Cleared 510(K)
- K881781CATHETER STRAP2Cleared 510(K)
- K881363SYRINGE PREFILLED WITH WATER2Cleared 510(K)
- K881646UROLOGICAL CATHETER2Cleared 510(K)
- K880100COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING2Cleared 510(K)
- K875383LAKE CATHETER CARE KITS (MODIFICATION)2Cleared 510(K)
- K874112VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K874682MMG CATHETER PLUG W/DRAINAGE TUBE COVER2Cleared 510(K)
- K874525MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR2Cleared 510(K)
- K874312ACKRAD RETROGRADE URETHROGRAPHY SET2Cleared 510(K)
- K874293ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET2Cleared 510(K)
- K873448FOLEY CATHETER TEMPERATURE SENSOR2Cleared 510(K)
- K874517PHARMASEAL RUBBER URETHRAL CATHETER2Cleared 510(K)
- K873287IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)2Cleared 510(K)
- K873435LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET2Cleared 510(K)
- K872750LAKE CATHETER CARE KIT2Cleared 510(K)
- K871429ANTIMICROBIAL FOLEY CATHETER2Cleared 510(K)
- K864592JUDD URETHAL CATHETER CONTAINER2Cleared 510(K)
- K870165FOLEY CATHETER2Cleared 510(K)
- K871297KADIR HI-TORQUE GUIDE WIRE2Cleared 510(K)
- K870977PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE2Cleared 510(K)
- K870557VAN-TEC PUMPING SYSTEM2Cleared 510(K)
- K870694VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER2Cleared 510(K)
- K864736AKRO-SIL PLUS2Cleared 510(K)
- K861699CATHETER VALVES KV 100 & KV 100EH2Cleared 510(K)
- K862098PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH2Cleared 510(K)
- K863082COOK-VPI INTERMITTENT CATHETER2Cleared 510(K)
- K863958TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY2Cleared 510(K)
- K863354BIO-GUARD AB COATED CATHETER2Cleared 510(K)
- K863517FOLEY CATHETERS2Cleared 510(K)
- K863282CARE + PLUS CATHETER CARE TRAY2Cleared 510(K)
- K863281CARE + PLUS IRREGATION TRAY2Cleared 510(K)
- K863302MODIFIED FOLEY CATHETER2Cleared 510(K)
- K862484HCI Y-CONNECTOR2Cleared 510(K)
- K860325PRISTINE CULTURE CATHETER2Cleared 510(K)
- K862124POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K861200UROTOPO CATHETER2Cleared 510(K)
- K861181NORTA TEFLON COATED LATEX BALLOON CATHETERS2Cleared 510(K)
- K860265TELESCOPE PROTECTION TUBE2Cleared 510(K)
- K860337VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.2Cleared 510(K)
- K860484CURITY & KENGUARD SILICONE COATED FOLEY CATHETER2Cleared 510(K)
- K855143ANGIOMED EXCHANGE DRAINAGE CATHETER SETS2Cleared 510(K)
- K855076ANGIOMED URETER DIATION SETS2Cleared 510(K)
- K854625UROTEC CLOSED IRRIGATIION SYRINGE2Cleared 510(K)
- K855140ANGIOMED RENAL DILATION SET2Cleared 510(K)
- K855077ANGIOMED HARZMANN DISCS2Cleared 510(K)
- K854443O'NEIL URINARY CATHETER INTRODUCER2Cleared 510(K)
- K852084KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP2Cleared 510(K)
- K853207PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE2Cleared 510(K)
- K853337TROCAR/CANNULA/SHEATH SET2Cleared 510(K)
- K851160VAN-TEC GUIDE WIRE W/HYDROMER COATING2Cleared 510(K)
- K851857UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER2Cleared 510(K)
- K851684UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER2Cleared 510(K)
- K851180IRRIGATION TRAY2Cleared 510(K)
- K851179CATHETER CARE TRAY2Cleared 510(K)
- K850790DIAFLEX OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K850335URETEROSCOPY CATHETER2Cleared 510(K)
- K850285GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY2Cleared 510(K)
- K842420NORTA SILICONIZED LATEX BALLOON CATH.2Cleared 510(K)
- K842866URETHRAL CATHETERIZATION TRAY2Cleared 510(K)
- K842228AIMED FOLEY CATHETER VARIOUS SIZES2Cleared 510(K)
- K842890PERCUFIX CATHETER CUFF2Cleared 510(K)
- K841769INTERMITTENT URETHRAL CATHETER TRAY2Cleared 510(K)
- K841941VAN-TEC OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K841819CORPAK FOLEY CATH TRAY W/16FR. TEFLON2Cleared 510(K)
- K841678STERILE, FOLEY CATHETERS W/PTFE COAT2Cleared 510(K)
- K841511HAEMATURIA CATHETERS2Cleared 510(K)
- K841544AMER. PHARMASEAL SILICONIZED LATEX2Cleared 510(K)
- K841727UROLOGICAL CATHETER & ACCESSORIES2Cleared 510(K)
- K841485UROLOGICAL KIT W/STERILE, WATER-FILL2Cleared 510(K)
- K840839MMG FOLEY CATHETER2Cleared 510(K)
- K832363FOLEY CATHETERIZATION TRAY-VARIOUS2Cleared 510(K)
- K834438TEMPERATURE SENSING FOLEY CATHETER2Cleared 510(K)
- K833719PREPACELL THIN NEEDLE ASPIRATION TRAY2Cleared 510(K)
- K833432CATHETER INSERTION KIT2Cleared 510(K)
- K833790CURITY 100% SILICONE COUDE' CATHETER2Cleared 510(K)
- K832389CATHETER CARE TRAY2Cleared 510(K)
- K832692CURITY CATHETER STRAP2Cleared 510(K)
- K831743STERILE FOLEY CATHETERS & UROLOGICAL2Cleared 510(K)
- K831567FOLEY-TEMP2Cleared 510(K)
- K832165IMPROVED SILICATH SILICONE ELASTOMER2Cleared 510(K)
- K831244URETERAL STONE EXTRACTOR CATHETER2Cleared 510(K)
- K831369LATEX URINARY CATHETERS2Cleared 510(K)
- K830359STERILE CATHERIZATION PROCEDURE TRAYS2Cleared 510(K)
- K830444STERILE, ALL PURPOSE URETHRAL CATHETER2Cleared 510(K)
- K823818CATHETER HOLDER2Cleared 510(K)
- K821818RETRIEVAL BALLOONS2Cleared 510(K)
- K821970DYNACOR URETHRAL CATHETER TRAY2Cleared 510(K)
- K821745BARDEX ALL SILICONE PEDIATRIC CATHETER2Cleared 510(K)
- K821272BN-74 COATED BARDEX ALL SILICONE CATH2Cleared 510(K)
- K820987FOLEY INSERTION TRAYS W/OVERWRAY2Cleared 510(K)
- K820838CURITY ECONOMY I CYSTOSCOPY2Cleared 510(K)
- K820868URETERAL CATHETER CONNECTOR2Cleared 510(K)
- K820866URETERAL CATHETER CONNECTING TUBE2Cleared 510(K)
- K820239RETRIEVAL FORCEPS2Cleared 510(K)
- K820637CATH-HOLD2Cleared 510(K)
- K820419AM. PH. STERILE SINGLE-USE URETHRAL CATH2Cleared 510(K)
- K820313VPI-FAIR URETHRAL STENT2Cleared 510(K)
- K812995VANCE-JACOBELLIS MICROHEMATURIA CATHETER2Cleared 510(K)
- K812887ROBINSON CATHETERS NON-STERILE2Cleared 510(K)
- K811924PRE-FILLED SYRINGE & CYSTOFLO URINARY BG2Cleared 510(K)
- K812281TOUCHLESS HOME-CATH2Cleared 510(K)
- K811277CATH-DAP2Cleared 510(K)
- K810690CURITY 100% SILICONE SAFETY INDICATOR2Cleared 510(K)
- K810249TRAY, CATHERIZATION, URETHRAL2Cleared 510(K)
- K810630SILICONE ELASTOMER COATED LATEX FOLEY2Cleared 510(K)
- K810372VANCE DEFLECTABLE BIOPSY BRUSH SET2Cleared 510(K)
- K810367KISH URETHRAL ILLUMINATED CATHETER SET2Cleared 510(K)
- K810281UROLOGICAL CATHETERS2Cleared 510(K)
- K810216ARGYLE ROB-NELS2Cleared 510(K)
- K803259CLOSED SYSTEM URETHRAL CATHETERIZ. SET2Cleared 510(K)
- K803062CATH-SECURE2Cleared 510(K)
- K802878K-KATH URETHRAL CATHETER INTRODUCER2Cleared 510(K)
- K803080ALL PUPOSE URETHRAL CATHETER2Cleared 510(K)
- K803079FOLEY CATHETER2Cleared 510(K)
- K802875ARGYLE HEMATURIA BALLOON CATHETER2Cleared 510(K)
- K802665TOUCHLESS CLEAN-CATH2Cleared 510(K)
- K802516FOLEY CATHETER2Cleared 510(K)
- K801820FOLEY CATHETERIZATION TRAY2Cleared 510(K)
- K801785URETHRAL CATHETERIZATION TRAYS2Cleared 510(K)
- K801787URINARY CATHETER CARE TRAYS #3700&37102Cleared 510(K)
- K801786URINE COLLECTION CONTAINERS, #3600 &36102Cleared 510(K)
- K802083CATHETER INSERTION TRAY2Cleared 510(K)
- K801415LATEX FOLEY CATHETER (HYDROMER COATED)2Cleared 510(K)
- K801784URINARY CATHETERS #3400,3410 &34202Cleared 510(K)
- K800609CATHETER STYLET2Cleared 510(K)
- K800505URETHRAL CATHETER2Cleared 510(K)
- K800307IRRIGATION (3-WAY) FOLEY CATHETER2Cleared 510(K)
- K800308PEDIATRIC FOLEY CATHETER2Cleared 510(K)
- K800306FOLEY CATHETER2Cleared 510(K)
- K7927193 WAY URETHRAL IRRIGATION CATHETER2Cleared 510(K)
- K792220VANCE KIDNEY BIOPSY BRUSHES2Cleared 510(K)
- K792109CONPHAR LATEX FOLEY CATH-STERILE2Cleared 510(K)
- K792111CONPHAR SILICONE COATED FOLEY CATH2Cleared 510(K)
- K792107CONPHAR 100% SILICONE FOLEY CATH-STER.2Cleared 510(K)
- K791598CLOSED SYSTEM FOLEY CATHERIZATION PROCED2Cleared 510(K)
- K792038NELATON CATHETER2Cleared 510(K)
- K792037NON-A-THERM2Cleared 510(K)
- K791674BLADDER RETENTION CATHETERIZATION TRAY2Cleared 510(K)
- K791992DYNACOR STERILE CARELON SILICONE CATH.2Cleared 510(K)
- K791717BARD URODYNAMIC CATHETERS2Cleared 510(K)
- K791427CATHETERIZATION TRAYS FOLEY AND URETHRAL2Cleared 510(K)
- K791244CONPHAR FEMALE CATHETER-STERILE2Cleared 510(K)
- K791332UNIVERSAL FOLEY CATHETER TRAY2Cleared 510(K)
- K791264CONPHAR NELATON CATHETER-STERILE2Cleared 510(K)
- K790728TOUCHLESS TM FOLEY CATHETER KIT2Cleared 510(K)
- K781751CATHETER, AKRON FOLEY TEFLON2Cleared 510(K)
- K781457FOLEY CATHETERS2Cleared 510(K)
- K760897STERILE URETHRAL CATHETER KIT2Cleared 510(K)
- K780676STERILE CLOSED SYSTEM2Cleared 510(K)
- K780675STERILE 100% SILICONE FOLEY CATHETER2Cleared 510(K)
- K770814CATHETER, URETHERAL2Cleared 510(K)
- K771779CATHETERIZATION SYS. URINARY DRAINAGE2Cleared 510(K)
- K770562HANDLER CATHETER2Cleared 510(K)
- K770489CATHETER WITH HARD VALVE2Cleared 510(K)
- K770493TRAVACATH2Cleared 510(K)
- K770256CATHETERS, SILICONE COATED2Cleared 510(K)
- K761144FEM CATH (URETHRAL CATHETER)2Cleared 510(K)
- K760858RUTNER UNIVERSAL WEDGE CATHETER2Cleared 510(K)
- K761059MALE URINARY CATHETER, EXTERNAL2Cleared 510(K)
- K760440CATHETER, NATURAL LATEX URETHRAL2Cleared 510(K)
- K760259CATHETER 3-WAY SILICONE FOLEY2Cleared 510(K)
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISLAND BIOSURGICAL BNS KIT #3
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K001583
- 510(k) Type
- Traditional
- Applicant
- Island Biosurgical, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/13/2000
- Days to Decision
- 52 days
- Submission Type
- Summary