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
- K110518IBAG2Cleared 510(K)
- K9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG2Cleared 510(K)
- K972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG2Cleared 510(K)
- K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEM2Cleared 510(K)
- K971929AMSINO URINARY LEG BAG2Cleared 510(K)
- K971764WELCON HUE-VU URINARY DRAINAGE BAG2Cleared 510(K)
- K964690LIBERTY VALVE2Cleared 510(K)
- K964745AMSINO URINARY DRAINAGE BAG2Cleared 510(K)
- K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)2Cleared 510(K)
- K960949PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 6501672Cleared 510(K)
- K952208PROSYS LEG BAG2Cleared 510(K)
- K944377ORION'S URINARY DRAINAGE SET2Cleared 510(K)
- K944236NEEDLELESS URINE SAMPLING PORT2Cleared 510(K)
- K940206BARD URINE COLLECTION PRODUCTS MODIFICATION2Cleared 510(K)
- K941447SIMPLA S4, S5, S72Cleared 510(K)
- K935557URINARY DRAINAGE BAG2Cleared 510(K)
- K931459KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER2Cleared 510(K)
- K925067SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG2Cleared 510(K)
- K926570HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 98782Cleared 510(K)
- K921024URO-TOTE LEG BAG2Cleared 510(K)
- K913142BODEN WHEELCHAIR DRAINAGE SYSTEM2Cleared 510(K)
- K913223STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES2Cleared 510(K)
- K901320ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG2Cleared 510(K)
- K902417BAG, URINE2Cleared 510(K)
- K896688URINE COLLECTOR LEG BAG2Cleared 510(K)
- K895168URO-BAGGIE2Cleared 510(K)
- K8967274 SURE URINARY DRAIN BAG2Cleared 510(K)
- K896579GOOSEN URINARY DRAINAGE SYSTEM2Cleared 510(K)
- K895957L.T.C. 1000 URINARY DRAINAGE BAG2Cleared 510(K)
- K892437KENDALL KENGUARD URINARY LEG BAGS2Cleared 510(K)
- K892433KENDALL CURITY URINARY DRAINAGE BAGS2Cleared 510(K)
- K890550CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)2Cleared 510(K)
- K890551URINARY DRAINAGE UNIT2Cleared 510(K)
- K881678SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP2Cleared 510(K)
- K881217GENT-L-KARE STERILE URINARY LEG BAG2Cleared 510(K)
- K881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER2Cleared 510(K)
- K880034CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT2Cleared 510(K)
- K874309URETHAL CATHETER2Cleared 510(K)
- K872824P. URINE METER, 250CC2Cleared 510(K)
- K873136MMG CATH-N-PLACE2Cleared 510(K)
- K871643CONVEEN(R) LEG-BAG (600 ML)2Cleared 510(K)
- K871610CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)2Cleared 510(K)
- K871387SECOND NATURE(TM)2Cleared 510(K)
- K870504NORTA (TM) UROBAG2Cleared 510(K)
- K871042URINE METER, 250CC2Cleared 510(K)
- K864188E-Z HOLD WITH ADHESIVE BASE.-#40652Cleared 510(K)
- K863739BESCURE2Cleared 510(K)
- K863671PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB52Cleared 510(K)
- K862581NEPHROSTOMY CONNECTING TUBE (A-50)2Cleared 510(K)
- K862580NEPHROSTOMY DRAINAGE KIT (A-150)2Cleared 510(K)
- K862251MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE2Cleared 510(K)
- K862934HOLLISTER FEMALE URINARY COLLECTION POUCH2Cleared 510(K)
- K860362SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER2Cleared 510(K)
- K854821MMG EXTERNAL FEMALE CATHETERS2Cleared 510(K)
- K861192GENTLE BACK, PLASTIC URINARY DRAINAGE BAG2Cleared 510(K)
- K861251AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N2Cleared 510(K)
- K855209NIR LAT MALE EXTERNAL CATHETER2Cleared 510(K)
- K854580CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH2Cleared 510(K)
- K853892VISTA MED-URISTAT2Cleared 510(K)
- K854480URINARY DRAINAGE BAG2Cleared 510(K)
- K852490URI-CATH SYSTEM2Cleared 510(K)
- K854173UCD URINE SPECIMEN COLLECTOR2Cleared 510(K)
- K853458H-H SEXTON SCUP URINE MGMT. SYS2Cleared 510(K)
- K852619URI-SURE2Cleared 510(K)
- K852051EXTERNAL MALE CATHETER2Cleared 510(K)
- K852085KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG2Cleared 510(K)
- K844810NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG2Cleared 510(K)
- K851681SAFESTRETCH INCONTINENCE SYSTEM2Cleared 510(K)
- K851266QRI-FLOW URINE FLOW MEASURING DEVICE2Cleared 510(K)
- K851470BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR2Cleared 510(K)
- K851471TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR2Cleared 510(K)
- K844155STANDARD URINARY DRAINAGE BAG & LEG BAG2Cleared 510(K)
- K844801ULTRA EXTERNAL CATHETER2Cleared 510(K)
- K844684COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM2Cleared 510(K)
- K843128FEMALE URINARY INCONTINENCE SYS2Cleared 510(K)
- K844280TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE2Cleared 510(K)
- K843698CLOSED URINARY DRAINAGE UNIT2Cleared 510(K)
- K843478PHARMA-PLAST URIDROP-URIDOME2Cleared 510(K)
- K843481PHARMA-PLAST CONNECTING TUBE TYPE URIN-2Cleared 510(K)
- K843480PHARMA-PLAST URINARY DRAINAGE BAG 20002Cleared 510(K)
- K843479PHARMA-PLAST LEG BAG2Cleared 510(K)
- K843117GREEN CROSS URINARY DRAINAGE BAG2Cleared 510(K)
- K843126MEDIFLEX DRAINAGE BAG2Cleared 510(K)
- K842396ACCUSEAL LEG BAGS & EXTENSION TUBES2Cleared 510(K)
- K842397URIHESIVE SYS MALE EXTERNAL CATHETER2Cleared 510(K)
- K842395SUR-FIT NIGHT DRAINAGE CONTAINER SET2Cleared 510(K)
- K842257CORPAK URINARY DRAINAGE BAG2Cleared 510(K)
- K832290CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE2Cleared 510(K)
- K842553CHESEBROUGH-POND'S REUSABLE URINARY LEG2Cleared 510(K)
- K841197CYSTO-AID2Cleared 510(K)
- K841169CURITY RIG FOLEY CATH TRAY2Cleared 510(K)
- K841224URO-MALE INCONTINENCE CATHETER2Cleared 510(K)
- K840917URINARY MONITORING SYS 2402Cleared 510(K)
- K840283MULTIPLE BAG, LEG2Cleared 510(K)
- K840284MULTIPLE SYS-URINE DRAINAGE-CLOSED2Cleared 510(K)
- K840702SECURE W/25MM DIAM. SHEATH & ADHESIVE2Cleared 510(K)
- K840704SECURE W/35MM DIAM, SHEATH/ADHESIVE2Cleared 510(K)
- K840703SECURE W/30MM DIAM, SHEATH & ADHESIVE2Cleared 510(K)
- K840292URETHRAL CATH. TRAY W/BAG2Cleared 510(K)
- K834448URINARY DRAINAGE CONTAINER2Cleared 510(K)
- K834337URIHESIVE SYSTEM - IMPROVED2Cleared 510(K)
- K833570COLOPLAST BABY URINE COLLECTORS2Cleared 510(K)
- K831530PLASTIC LEG BAG2Cleared 510(K)
- K833245SECURITY STRETCH BRIEF-MEDICAL2Cleared 510(K)
- K832822CLOSED SYS. DRAINAGE BAGS & TRAYS2Cleared 510(K)
- K832450URO-TEX MALE EXTERNAL CATHETER2Cleared 510(K)
- K832526UROTRACK PLUS2Cleared 510(K)
- K832537CONVEEN LEG BAG W/TUBE-DRAINAGE BAG2Cleared 510(K)
- K831622MORHEL CLOSED URINARY DRAINAGE SET2Cleared 510(K)
- K831796URINE BAG SYSTEM2Cleared 510(K)
- K832107LEG BAG EXTENTION TUBE-STERILE2Cleared 510(K)
- K832106EXTERNAL INCONTINENCE CATHETER TRAVEL2Cleared 510(K)
- K832108EXTERNAL INCONTINENCE CATHETER SET-NON2Cleared 510(K)
- K832109EXTERNAL INCONTINENCE CATHETER TAKE-HOME2Cleared 510(K)
- K831553LEG DRAINAGE BAG STRAP BK60112Cleared 510(K)
- K831121CURITY LEG BAG2Cleared 510(K)
- K830946MALE EXTERNAL CATHETER2Cleared 510(K)
- K830192MAC LEE UI URINE COLLECTION BAG2Cleared 510(K)
- K823716CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC2Cleared 510(K)
- K823450FEMALE EXTERNAL URINARY APPLIANCE2Cleared 510(K)
- K823411PEDIATRIC URINE COLLECTOR2Cleared 510(K)
- K822307ADHESIVE SPRAY #4050-40602Cleared 510(K)
- K821979STERILE FOLEY CATHETERIZATION KITS2Cleared 510(K)
- K821978STERILE URETHRAL CATHETERIZATION SET2Cleared 510(K)
- K821848ASSURE-MALE EXTERNAL INCONTINCE CATHETER2Cleared 510(K)
- K821829UROGARD2Cleared 510(K)
- K821854U-200 BAG2Cleared 510(K)
- K821853U-100 BAG2Cleared 510(K)
- K821168DISPOSABLE URINARY LEGBAG W/STRAP2Cleared 510(K)
- K821171URINARY COLLECTION CONTAINER/LEG BAG2Cleared 510(K)
- K821161EXTERNAL URINARY MALE INCONTINENCE DEV2Cleared 510(K)
- K821172EXTERNAL FEMALE URINARY INCONTINENCE2Cleared 510(K)
- K820565MALE EXTERNAL CATHETER2Cleared 510(K)
- K813621CURITY BEDSIDE DRAINAGE BAG2Cleared 510(K)
- K820234HOLLISTER FEMALE URINARY COLLECT SYS2Cleared 510(K)
- K820136URINARY DRAINAGE BAG2Cleared 510(K)
- K813537URIFIX2Cleared 510(K)
- K813479ARGYLE PEDIATRIC URINE COLLECTOR2Cleared 510(K)
- K812907FEMEX2Cleared 510(K)
- K812249SKIN ADHESIVE-50XX2Cleared 510(K)
- K812294CONVEEN URISHEATH & CONVEEN URILINER2Cleared 510(K)
- K812250CONDOM-52.XX2Cleared 510(K)
- K812251DISPOSABLE URINE GAB-70.XX2Cleared 510(K)
- K812252LATEX LEG BAG-57.XX2Cleared 510(K)
- K812058AKRON URINARY DRAINAGE BAT2Cleared 510(K)
- K811469MMG URINARY DRAINAGE TUBING2Cleared 510(K)
- K810645SELECT-A-FLOW COLLECTOR2Cleared 510(K)
- K802729URINE COLLECTION BAG TYPE 2132V2Cleared 510(K)
- K802732URINE COLLECTION BAG TYPE AP2132V2Cleared 510(K)
- K802739URINE COLLECTION BAG TYPE 710AP2Cleared 510(K)
- K802738URINE COLLECTION BAG TYPE 1505V2Cleared 510(K)
- K802737URINE COLLECTION BAG TYPE 1590V2Cleared 510(K)
- K802734URINE COLLECTION BAG TYPE 7102Cleared 510(K)
- K802733URINE COLLECTION BAG TYPE AP2090V2Cleared 510(K)
- K802736URINE COOLECTION BAG TYPE 2090V2Cleared 510(K)
- K802735URINE COLLECTION BAG TYPE 740AP2Cleared 510(K)
- K802667ARGYLE CLOSED URINARY DRAINAGE SET2Cleared 510(K)
- K802664URINARY DRAINAGE UNT2Cleared 510(K)
- K802606LEG BAG EXTENSION TUBE2Cleared 510(K)
- K802433BARD MALE EXTERNAL CATHETER2Cleared 510(K)
- K802172URIHESIVE SYSTEM2Cleared 510(K)
- K802173URIHESIVE STRIPS2Cleared 510(K)
- K802012TRIBAG, URINE BAG SYSTEM #1109,& 1301-122Cleared 510(K)
- K801711BK-6010 CATHETER TUBE HOLDER2Cleared 510(K)
- K801629COVER-ALL MALE INCONTINENCE DEVICE2Cleared 510(K)
- K801522ARGYLE RIGID URINE MEASURING/COLL. DEV.2Cleared 510(K)
- K801021URINEBAG2Cleared 510(K)
- K800890LINEBERGER EXTERNAL MALE CATHETER2Cleared 510(K)
- K800694MMG DISPOSABLE URINARY LEG BAG2Cleared 510(K)
- K800186LOGO-NU-WAY2Cleared 510(K)
- K791969DYNACOR STERILE CLOSED SYS. DRAINAGE BAG2Cleared 510(K)
- K791252CONPHAR FEMALE CATHETER W/BAG-STERILE2Cleared 510(K)
- K791265CONPHAR URINARY DRAINAGE BAG-2000ML2Cleared 510(K)
- K791245CONPHAR EXTERNAL CATHETER2Cleared 510(K)
- K791262CONPHAR URINARY DRAINAGE BAG 2000ML2Cleared 510(K)
- K791251CONPHAR LEG BAG-STERILE2Cleared 510(K)
- K791270CONPHAR LEG BAG2Cleared 510(K)
- K791198BIBAG2Cleared 510(K)
- K791196URIDROP2Cleared 510(K)
- K790969ARGYLE URINE METER2Cleared 510(K)
- K790253URINARY DRAINAGE BAG2Cleared 510(K)
- K790279CATHETER, MMG LATEX EXTERNAL2Cleared 510(K)
- K790174BK-6021 CONDOM CATHETER HOLDER2Cleared 510(K)
- K781780CATHETER, EXTERNAL MALE NURSING CARE2Cleared 510(K)
- K781521CUTTER RESIFLEX URINE METER2Cleared 510(K)
- K781433AKRON MALE EXTERNAL CATHETER2Cleared 510(K)
- K781422KWIK-FLO URINAL SYSTEM2Cleared 510(K)
- K780878LEG BAG2Cleared 510(K)
- K780837URINARY DRAINAGE BAG2Cleared 510(K)
- K780831URINARY CATHETERIZATION SYSTEM W/O FOLEY2Cleared 510(K)
- K770789URI-DRAIN COMBO KIT FOR MALE INCONTINENC2Cleared 510(K)
- K771435URINARY LEG BAG, STEOILE2Cleared 510(K)
- K770762BAG, URINARY, DRAINAGE, 2D90132Cleared 510(K)
- K770673COLLECTOR, SANI-CATCH, NO. 10142Cleared 510(K)
- K770672COLLECTOR, SANI-CATCH, NO. 10102Cleared 510(K)
- K770516MEMBRANE SOURCE-EX SERIES DIALYZER CART.2Cleared 510(K)
- K770557DRAINAGE BAG, 4000 ML.2Cleared 510(K)
- K770497DRAINAGE UNIT, COMBINATION2Cleared 510(K)
- K770490DRAINAGE BAG, IMPROVED, FLAT2Cleared 510(K)
- K770320URINARY DRAINAGE SET, CLOSED, STERILE2Cleared 510(K)
- K770399VALVE FOR CLOSED SYS. URINARY DRAINAGE2Cleared 510(K)
- K7613608 LATEX EXTENSION TUBE WITH CONNECTOR2Cleared 510(K)
- K761039URINARY LEG BAG DRAINAGE TUBE2Cleared 510(K)
- K760260BAG, DISPOSABLE URINARY LEG2Cleared 510(K)
- K760069BAG, LEG, URINE COLLECTING DEVICE2Cleared 510(K)
- K760105BAG, URINE COLLECTION, CLOSED SYSTEM2Cleared 510(K)
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- 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
- 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
SIMPLA S4, S5, S7
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K941447
- 510(k) Type
- Traditional
- Applicant
- SIMPLA PLASTICS LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/18/1994
- Days to Decision
- 116 days
- Submission Type
- Statement