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
- K250389XNY Disposable Gastric Calibration Tube2Cleared 510(K)
- K243228Flexi-Seal AIR (with ENFit Connector)2Cleared 510(K)
- K242336hygh-tec Drainage II2Cleared 510(K)
- K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)2Cleared 510(K)
- K241169Entarik NI Feeding Tube System2Cleared 510(K)
- K241185CORGRIP* SR NG/NI Tube Retention System2Cleared 510(K)
- K240965CORTRAK* 2 Enteral Access System (20-0950)2Cleared 510(K)
- K233591Stylus2Cleared 510(K)
- K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)2Cleared 510(K)
- K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)2Cleared 510(K)
- K240039Enteral Feeding Sets2Cleared 510(K)
- K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)2Cleared 510(K)
- K234145ViSiGi 3D Gastric Sizing Tube2Cleared 510(K)
- K222846AMT G-Tube Balloon Gastrostomy Feeding Device2Cleared 510(K)
- K230206Entarik Feeding Tube System; Entarik Feeding Tube2Cleared 510(K)
- K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)2Cleared 510(K)
- K230131ReShape Calibration Tubes2Cleared 510(K)
- K221400hygh-tec drainage2Cleared 510(K)
- K222085Standard Tapered Bougie, 38 Fr.2Cleared 510(K)
- K212316DoubleChek DC-10012Cleared 510(K)
- K221898Gastrointestinal Boundary Identifier (GIBI HD)2Cleared 510(K)
- K212407Gastric Lightguide (GLG)2Cleared 510(K)
- K220455Lap-Band System Calibration Tube2Cleared 510(K)
- K220218Siren SGT2Cleared 510(K)
- K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)2Cleared 510(K)
- K212444Qora Stool Management Kit2Cleared 510(K)
- K212728Standard Bougie, 38 Fr. and Hand Pump2Cleared 510(K)
- K210437Standard Bougie, 38 Fr.2Cleared 510(K)
- K211072Safety Trocar Cannula2Cleared 510(K)
- K202748Enteral Feeding Catheter2Cleared 510(K)
- K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube2Cleared 510(K)
- K200646TubeClear System2Cleared 510(K)
- K202539Nutriglide(TM) Nasal Feeding Tube2Cleared 510(K)
- K201322Entuit Nasal Jejunal Feeding Tube2Cleared 510(K)
- K191885Standard Bougie2Cleared 510(K)
- K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches2Cleared 510(K)
- K190977Navina Smart System, Navina Classic System2Cleared 510(K)
- K190084McLean-Ring Enteral Feeding Tube Set2Cleared 510(K)
- K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube2Cleared 510(K)
- K191340CORTRAK* 2 Equilateral Enteral Access System2Cleared 510(K)
- K183336Entuit PEG, Entuit PEGJ2Cleared 510(K)
- K183577Medline Quick-Clear Wand2Cleared 510(K)
- K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)2Cleared 510(K)
- K183508Micro Transgastric-Jejunal Feeding Device2Cleared 510(K)
- K182804Traditional Length GJ Feeding Device2Cleared 510(K)
- K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube2Cleared 510(K)
- K182248Aspire Venting Tube2Cleared 510(K)
- K180605GastroFlush2Cleared 510(K)
- K180622Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port2Cleared 510(K)
- K180725Aspire Introducer Needle2Cleared 510(K)
- K172556TubeClear System2Cleared 510(K)
- K180026Bowel Management Device, Bowel Management Irrigation Set2Cleared 510(K)
- K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device2Cleared 510(K)
- K173355Gastric Sizing Balloon Catheter2Cleared 510(K)
- K162340Stomach Tube2Cleared 510(K)
- K170319Low Profile Non-Balloon Feeding Device2Cleared 510(K)
- K170487Navina Classic System2Cleared 510(K)
- K160567Barone Jejunostomy Catheter Set2Cleared 510(K)
- K160509Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube2Cleared 510(K)
- K163002Kangaroo Feeding Tube with IRIS Technology2Cleared 510(K)
- K162906Flexi-Seal PROTECT Fecal Management System2Cleared 510(K)
- K161413Low Profile Balloon Feeding Device2Cleared 510(K)
- K163092TubeClear Control Box and Clearing Stem2Cleared 510(K)
- K162110CORGRIP NG/NI Tube Retention System2Cleared 510(K)
- K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet2Cleared 510(K)
- K152246Aquarius Stoma Measuring Device2Cleared 510(K)
- K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit2Cleared 510(K)
- K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)2Cleared 510(K)
- K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm2Cleared 510(K)
- K140310Peristeen Anal Irrigation System2Cleared 510(K)
- K150350Flexi-Seal Signal Fecal Management System2Cleared 510(K)
- K142548MIDSLEEVE2Cleared 510(K)
- K142327smARTrack Feeding Tube System2Cleared 510(K)
- K142971AMT Bridle - Nasal Tube Retention System2Cleared 510(K)
- K143088GastriSail Gastric Positioning System2Cleared 510(K)
- K142816AbbVie J2Cleared 510(K)
- K142793AbbVie PEG2Cleared 510(K)
- K142792AbbVie NJ2Cleared 510(K)
- K143378AQUARIUS Gastrostomy Replacement Tube2Cleared 510(K)
- K133334VERITRACT ENTERAL FEEDING TUBE SYSTEM2Cleared 510(K)
- K141631AQUARIUS EXTENSION FEEDING SET2Cleared 510(K)
- K133077GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET2Cleared 510(K)
- K133465CONSURE STOOL MANAGEMENT SYSTEM2Cleared 510(K)
- K133129ABBVIE NJ2Cleared 510(K)
- K133087ABBVIE PEG2Cleared 510(K)
- K133096ABB VIE J2Cleared 510(K)
- K131183MED-RX ORAL/ENTERAL SYRINGE2Cleared 510(K)
- K132686AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K133251BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM2Cleared 510(K)
- K123555KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY2Cleared 510(K)
- K133599CORGRIP2Cleared 510(K)
- K132424METRIXCARE2Cleared 510(K)
- K133881MACY CATHETER2Cleared 510(K)
- K130674ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K130611ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K131052TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)2Cleared 510(K)
- K131532ELECTROMAGNETIC TRANSMITTING STYLET2Cleared 510(K)
- K122653MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES2Cleared 510(K)
- K123716AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT2Cleared 510(K)
- K123804INSTAFLO BOWEL CATHETER SYSTEM KIT2Cleared 510(K)
- K130483BOEHRINGER GASTRIC SIZING TUBE2Cleared 510(K)
- K123659TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)2Cleared 510(K)
- K122030LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON2Cleared 510(K)
- K121571TUBECLEAR2Cleared 510(K)
- K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER2Cleared 510(K)
- K112511DOBBHOFF DUAL PORT FEEDING TUBE2Cleared 510(K)
- K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM2Cleared 510(K)
- K113719SAFETY SCREW CONNECTOR2Cleared 510(K)
- K120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES2Cleared 510(K)
- K112863ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN2Cleared 510(K)
- K112268CODAN SAFEFEED ENTERAL FEEDING RESERVOIR2Cleared 510(K)
- K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET2Cleared 510(K)
- K113351CORTRAK ENTERAL ACCESS DEVICE2Cleared 510(K)
- K102712MED GRAVITY SET, IMED PUMP SET2Cleared 510(K)
- K102741ENTERAL FEEDING BAG AND SETS2Cleared 510(K)
- K110804AMT G-J TUBE2Cleared 510(K)
- K112434BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION2Cleared 510(K)
- K110005SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE2Cleared 510(K)
- K110529ENDOFLIP GASTRIC TUBE2Cleared 510(K)
- K103254PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE2Cleared 510(K)
- K102572IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT2Cleared 510(K)
- K103109PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K102391BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM2Cleared 510(K)
- K102548FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE2Cleared 510(K)
- K101199GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,2Cleared 510(K)
- K100288NEOMED ENTERAL ONLY EXTENSION SET2Cleared 510(K)
- K100366MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY2Cleared 510(K)
- K100365FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV2Cleared 510(K)
- K092628ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET2Cleared 510(K)
- K100273INSTAFLO BOWEL CATHETER SYSTEM KIT2Cleared 510(K)
- K100173IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT2Cleared 510(K)
- K093653URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK2Cleared 510(K)
- K083770COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM2Cleared 510(K)
- K092418ENTRACARE GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K092049IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT2Cleared 510(K)
- K091637CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-09002Cleared 510(K)
- K091759SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H2Cleared 510(K)
- K083685ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 82852Cleared 510(K)
- K090559FOOTPRINT MEDICAL SILICONE FEEDING TUBE2Cleared 510(K)
- K083684ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX2Cleared 510(K)
- K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 320072Cleared 510(K)
- K082710SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET2Cleared 510(K)
- K082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)2Cleared 510(K)
- K0817392-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT2Cleared 510(K)
- K082654ENTERAL ONLY EXTENSION SET2Cleared 510(K)
- K081725ENTERAL PUMP SET, MODEL 20-10102Cleared 510(K)
- K082241THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H841047512Cleared 510(K)
- K080679MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-09002Cleared 510(K)
- K073598BARD DIGNICARE STOOL MANAGEMENT SYSTEM2Cleared 510(K)
- K080328MPS ACACIA ENTERAL FEEDING TUBE2Cleared 510(K)
- K073034AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)2Cleared 510(K)
- K080340COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG2Cleared 510(K)
- K072652ENTERAL FEEDING SPIKE ADAPTER2Cleared 510(K)
- K072756NON-IV ADAPTER FOR INFANT NG TUBE2Cleared 510(K)
- K072476THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT2Cleared 510(K)
- K072550SIGHTSURE OPERATIONAL INDICATOR, MODEL SS3012Cleared 510(K)
- K071579PEF TUBE2Cleared 510(K)
- K072787GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-1112Cleared 510(K)
- K071764REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT3602Cleared 510(K)
- K070449LUMILOC (TM) SAFETY INTRODUCER NEEDLE2Cleared 510(K)
- K070124GASTROSTOMY REPLACEMENT TUBE, MODEL 2532Cleared 510(K)
- K063061CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-09002Cleared 510(K)
- K063118BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE2Cleared 510(K)
- K061432HOSPIRA ENTERAL FEEDING SET, MODEL 206402Cleared 510(K)
- K061021ENTAKE STANDARD AND SAFETY PEG SYSTEM2Cleared 510(K)
- K052903PEDIATRIC FEEDING TUBE2Cleared 510(K)
- K051206Y2K2 ENTERNAL TUBE FLUID FILTER2Cleared 510(K)
- K051551SMALL INTESTINAL VIDEOSCOPE SYSTEM2Cleared 510(K)
- K042431PROCON22Cleared 510(K)
- K043203WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE2Cleared 510(K)
- K043044ANTI-I.V. ENTERAL FEEDING SYSTEM2Cleared 510(K)
- K042112INFANT FEEDING TUBE2Cleared 510(K)
- K041987CORTRAK2Cleared 510(K)
- K043258MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-022Cleared 510(K)
- K043114KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE2Cleared 510(K)
- K043027MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX202Cleared 510(K)
- K042572KENDALL CO2NFIRM NOW CO2 DETECTOR2Cleared 510(K)
- K042300AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM2Cleared 510(K)
- K041034SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)2Cleared 510(K)
- K030413Y2K2 ENTERNAL FEEDING MANAGER2Cleared 510(K)
- K032734CONVATEC FECAL MANAGEMENT SYSTEM2Cleared 510(K)
- K030784NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL2Cleared 510(K)
- K031492MOSSMED DUAL INTERMITTENT ASPIRATOR2Cleared 510(K)
- K033562FASTRAC GASTRIC ACCESS PORT KIT2Cleared 510(K)
- K030841COOK GASTRIC SIZING BALLOON CATHETER2Cleared 510(K)
- K022558NGT2Cleared 510(K)
- K031538ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT2Cleared 510(K)
- K030855MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT2Cleared 510(K)
- K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 20202Cleared 510(K)
- K023344INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE2Cleared 510(K)
- K022648ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 65212Cleared 510(K)
- K021493ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S2Cleared 510(K)
- K020120ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 62202Cleared 510(K)
- K021991MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE2Cleared 510(K)
- K020005INFANT FEEDING TUBES2Cleared 510(K)
- K014297ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P2Cleared 510(K)
- K021034MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER2Cleared 510(K)
- K020985MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER2Cleared 510(K)
- K020379PPD BALLOON DILATATION CATHETER2Cleared 510(K)
- K012113INDWELLING FECAL MANAGEMENT SYSTEM2Cleared 510(K)
- K010798RUSCH CANTOR TUBE2Cleared 510(K)
- K010797RUSCH MILLER-ABBOTT TUBE2Cleared 510(K)
- K012147DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE2Cleared 510(K)
- K01316214F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH2Cleared 510(K)
- K013144DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W2Cleared 510(K)
- K011343LH 500 ENTERAL FEEDING GRAVITY BAG SET2Cleared 510(K)
- K011341LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET2Cleared 510(K)
- K011340LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT2Cleared 510(K)
- K012476MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-20102Cleared 510(K)
- K011467ROSS EMBRACE PUMP SET2Cleared 510(K)
- K002838GASTRIC SUCTION AND DRAINAGE CATHETER2Cleared 510(K)
- K011077ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)2Cleared 510(K)
- K001916COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX2Cleared 510(K)
- K990365GASTRIC LAVAGE VALVE2Cleared 510(K)
- K993358SIGHTSURE OPERATION INDICATOR, MODEL SS3012Cleared 510(K)
- K994300NASOGASTRIC TUBE HOLDER, MODEL 1602Cleared 510(K)
- K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE2Cleared 510(K)
- K993296TRIP TONOMETRY CATHETER, 14F2Cleared 510(K)
- K991918NUTRISAFE EXTENSION TUBE2Cleared 510(K)
- K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT2Cleared 510(K)
- K991375BARD BALLOON INFLATION SYSTEM2Cleared 510(K)
- K992494FLEXIFLO ENTERAL FEEDING TUBE2Cleared 510(K)
- K992181TRIP TONOMETRY CATHETER, 8F2Cleared 510(K)
- K991668COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)2Cleared 510(K)
- K990863MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE2Cleared 510(K)
- K990389MOSS GASTROSTOMY TUBE2Cleared 510(K)
- K984628MODIFICATION OF MOSS P.E.G. TRAY2Cleared 510(K)
- K983476BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES2Cleared 510(K)
- K984310MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE2Cleared 510(K)
- K990127CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)2Cleared 510(K)
- K982500CHAIT CECOSTOMY CATHETER2Cleared 510(K)
- K983366TRIP TONOMETRY CATHETER, 16F2Cleared 510(K)
- K981323COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT2Cleared 510(K)
- K971434A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE2Cleared 510(K)
- K981203RUSCH BLAKEMORE 3 LUMEN, STERILE2Cleared 510(K)
- K973892RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)2Cleared 510(K)
- K980305AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE2Cleared 510(K)
- K974806VYGON NEO-SUMP2Cleared 510(K)
- K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS2Cleared 510(K)
- K972478PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES2Cleared 510(K)
- K972102RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT2Cleared 510(K)
- K972025RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT2Cleared 510(K)
- K971901RADIUS LOW PROFILE GASTROSTOMY TUBE KIT2Cleared 510(K)
- K973891LAPAROSCOPIC GASTROSTOMY KIT2Cleared 510(K)
- K973893AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE2Cleared 510(K)
- K971757LOW PROFILE FEEDING SET ACCESSORY2Cleared 510(K)
- K962554FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE2Cleared 510(K)
- K970849ENTERAL NUTRITION 1000 ML/500ML2Cleared 510(K)
- K970178CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM2Cleared 510(K)
- K964920RPI DUAL PORT IRRIGATION ADAPTER2Cleared 510(K)
- K971230SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT2Cleared 510(K)
- K970890#ES-32 SUCTION CATHETER 32 FR.2Cleared 510(K)
- K965087COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)2Cleared 510(K)
- K950017FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM2Cleared 510(K)
- K961664COMPAT NASOJEJUNAL FEEDING TUBE2Cleared 510(K)
- K963113FLEXIFLO POLYG GASTOSTOMY TUBE2Cleared 510(K)
- K961345DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE2Cleared 510(K)
- K962375MICROVASIVE BALLOON GASTROSTOMY TUBE KIT2Cleared 510(K)
- K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE2Cleared 510(K)
- K961884CATH CADDIE2Cleared 510(K)
- K955181U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K955248U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT2Cleared 510(K)
- K960677KANGAROO JEJUNAL FEEDING SYSTEM2Cleared 510(K)
- K960632KANGAROO FEEDING TUBE PLACMENT STYLET2Cleared 510(K)
- K960415WILSON-COOK BALLOON INFLATION DEVICE2Cleared 510(K)
- K960177P.E.G. PATIENT CARE KIT2Cleared 510(K)
- K954879PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)2Cleared 510(K)
- K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT2Cleared 510(K)
- K954776REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY2Cleared 510(K)
- K946249BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES2Cleared 510(K)
- K922567LOW PROFILE CATHETER2Cleared 510(K)
- K945618GASTROINTESTINAL TUBES & ACCESSORIES2Cleared 510(K)
- K941228ENDOLUMINAL ACCESS TUBE2Cleared 510(K)
- K953375NG SECURE2Cleared 510(K)
- K946140PRG BUTTON2Cleared 510(K)
- K953232HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE2Cleared 510(K)
- K923488GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY2Cleared 510(K)
- K931921CORPAK GASTROSTOMY TUBE2Cleared 510(K)
- K951489MRI'S ALL SILICONE GASTROSTOMY TUBE2Cleared 510(K)
- K932880GRASSI GASTROJEJUNOSTOMY TUBE2Cleared 510(K)
- K924306PERCUTANEOUS ENDOSCOPIC GASTROSTOMY2Cleared 510(K)
- K945612MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE2Cleared 510(K)
- K943240FLEXIFLO SIX ENTERAL NUTRITION PUMP SET2Cleared 510(K)
- K922217FLEXIFLO NASOENTERIC FEEDING TUBE2Cleared 510(K)
- K945012CATCO NUTRITIONAL CATHETER2Cleared 510(K)
- K940548MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE2Cleared 510(K)
- K921478GUARDPORT2Cleared 510(K)
- K922216FLEXIFLO TUBE PLACEMENT VERIFIER2Cleared 510(K)
- K943675ENTERAL DELIVERY SETS WITH HYDRATION PORT2Cleared 510(K)
- K924850VANSONNENBERG GASTROSTOMY CATHETER2Cleared 510(K)
- K943685MIC DISPOSABLE SNARE2Cleared 510(K)
- K935633NO-MES2Cleared 510(K)
- K923046BIOLOGIC DT-1000 MACHINE2Cleared 510(K)
- K933842KLEIN RECTAL TAMPNADE BALLOON2Cleared 510(K)
- K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS2Cleared 510(K)
- K926581MIC TRANSGASTRIC JEJUNAL TUBE2Cleared 510(K)
- K932295NON-BALLOON REPLACEMENT GASTROSTOMY KIT2Cleared 510(K)
- K935045BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER2Cleared 510(K)
- K920579LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE2Cleared 510(K)
- K923002ENTEROCLYSIS TUBE2Cleared 510(K)
- K925061HELLER TRANSILLUMINATING STYLETTE2Cleared 510(K)
- K923168DUAL PORT ENTERAL Y-ADAPTOR2Cleared 510(K)
- K932861FLEXIFLO GASTROSTOMY KIT2Cleared 510(K)
- K925102FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT2Cleared 510(K)
- K921680E-Z PEG2Cleared 510(K)
- K925854VYGON - ENTERAL FEEDING TUBE - POLYURETHANE2Cleared 510(K)
- K921652MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT2Cleared 510(K)
- K921370MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION2Cleared 510(K)
- K936168WILSON-COOK BALLOON INFLATION DEVICE2Cleared 510(K)
- K934772GASTRONOMY TUBE HOLDER2Cleared 510(K)
- K925261NUTRICARE ENTERAL FEEDING TUBE2Cleared 510(K)
- K924065MIC PEG TUBE2Cleared 510(K)
- K922998ENFUSE ENTERAL FEEDING TUBE2Cleared 510(K)
- K920703GASTROINTESTINAL FEEDING TUBE2Cleared 510(K)
- K922667MIC LOW PROFILE GASTROSTOMY TUBE2Cleared 510(K)
- K930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR2Cleared 510(K)
- K932855HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE2Cleared 510(K)
- K924996FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE2Cleared 510(K)
- K924697FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT2Cleared 510(K)
- K924308GASTROPORT II2Cleared 510(K)
- K9218534 SURE TM FEEDING TUBES2Cleared 510(K)
- K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC2Cleared 510(K)
- K923692STOMA MEASURING DEVICE2Cleared 510(K)
- K920262ONAT BALLOONED NASOGASTRIC TUBE2Cleared 510(K)
- K923983PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT2Cleared 510(K)
- K915837NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM2Cleared 510(K)
- K923474LOW PROFILE GASTROMSTOMY DEVICE2Cleared 510(K)
- K921127PANDA NEEDLE CATHETER JEJUNOSTOMY KIT2Cleared 510(K)
- K920493PEG PREP TRAY2Cleared 510(K)
- K922209NASOGRASTRIC TUBBE HOLDER2Cleared 510(K)
- K921697FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER2Cleared 510(K)
- K915735FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT2Cleared 510(K)
- K920894DECOMPRESSION TUBES2Cleared 510(K)
- K921026PRESSURE GAUGE2Cleared 510(K)
- K915110FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT2Cleared 510(K)
- K914375NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE2Cleared 510(K)
- K913997SAECG CARDIOGRAPH MODEL M1754A2Cleared 510(K)
- K913476GI BLEEDER/OD SET2Cleared 510(K)
- K915171LOPEZ VALVE TM II2Cleared 510(K)
- K913784DOBBHOFF(R) SINGLE PASS PEG KIT2Cleared 510(K)
- K913786FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP2Cleared 510(K)
- K900623ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE2Cleared 510(K)
- K913603FIBRETWINS2Cleared 510(K)
- K912047WILSON-COOK RUSSELL GASTROSTOMY KIT2Cleared 510(K)
- K910382FLEXIFLO ENTERAL FEEDING TUBE2Cleared 510(K)
- K911897GASPARAITIS ESOPHAGRAM CATHETER SET2Cleared 510(K)
- K910910MOSS- ANCHOR SET2Cleared 510(K)
- K910912MOSS NASAL TUBE MARK IV2Cleared 510(K)
- K910911MOSS P.E.G. TRAY2Cleared 510(K)
- K910913MOSS GASTROSTOMY TUBE2Cleared 510(K)
- K910332FLEXIFLO SACKS-VINE GASTROSTOMY KITS2Cleared 510(K)
- K905164TUBE DECLOGGER2Cleared 510(K)
- K902623FLEXIFLO STOMATE EXTENSION TUBE2Cleared 510(K)
- K903662PEEWEE REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K900464MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE2Cleared 510(K)
- K903579FLEXIFLO STOMATE DECOMPRESSION TUBE2Cleared 510(K)
- K903325FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT2Cleared 510(K)
- K902099WILSON-COOK VARICES TAMPONADE BALLOON CUFF2Cleared 510(K)
- K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKE2Cleared 510(K)
- K895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA2Cleared 510(K)
- K895142ENTERAL PUMP SET WITH ENTERAL SPIKE2Cleared 510(K)
- K902641RPI ENTERAL FEEDING BAG 1000ML AND 500ML2Cleared 510(K)
- K902684MIC ANAL INCONTINENCE TUBE2Cleared 510(K)
- K901835LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)2Cleared 510(K)
- K902729R.P.I. GRAVITY SAFE FEEDING BAG2Cleared 510(K)
- K900624DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM2Cleared 510(K)
- K900563DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH2Cleared 510(K)
- K900590BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING2Cleared 510(K)
- K900324DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE2Cleared 510(K)
- K901023GASTROINTESTINAL TUBES AND ACCESSORIES2Cleared 510(K)
- K901574ACKRAD MPR DRAINAGE CATHETER SET2Cleared 510(K)
- K901683IMPROVED BAKER TWIN-CUFF SUMP TUBE2Cleared 510(K)
- K901134ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K901753600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET2Cleared 510(K)
- K901130ENTERA-FLO FEEDING TUBE2Cleared 510(K)
- K900852MAGNET RETRIEVAL CATHETER2Cleared 510(K)
- K895933ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III2Cleared 510(K)
- K895919ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III2Cleared 510(K)
- K895696ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU2Cleared 510(K)
- K895330600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA2Cleared 510(K)
- K895366ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE2Cleared 510(K)
- K895246FRENTA(R) DUO-SET2Cleared 510(K)
- K896210GASTRIC SUMP TUBE2Cleared 510(K)
- K895706TUBING ORGANIZER2Cleared 510(K)
- K895616L.T.C. FEEDING TUBE2Cleared 510(K)
- K893888HOLLISTER FEEDING TUBE ATTACHMENT DEVICE2Cleared 510(K)
- K893540VINYL BAG W/PUMP ADMINISTRATION SET2Cleared 510(K)
- K893541VINYL BAG W/GRAVITY ADMINISTRATION SET2Cleared 510(K)
- K894857PEDI-TUBE(R) STYLET2Cleared 510(K)
- K885220PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT2Cleared 510(K)
- K891371GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG2Cleared 510(K)
- K893209ENTERA-FLO SPIKE SET2Cleared 510(K)
- K890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET2Cleared 510(K)
- K892439KENDALL CURITY STOMACH TUBES2Cleared 510(K)
- K890424ENTERAL FEEDING CONTAINER2Cleared 510(K)
- K890430ENTAINER(TM) ENTERAL FEEDING CONTAINER2Cleared 510(K)
- K890151ENTERAL BAG/SET2Cleared 510(K)
- K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE2Cleared 510(K)
- K890870BARD GASTROSTOMY FEEDING DEVICE2Cleared 510(K)
- K890871BARD MOSS(R) GASTROSTOMY TUBE2Cleared 510(K)
- K885339FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT2Cleared 510(K)
- K890552CP&S GAVAGE CONSTAINER, DISPOSABLE2Cleared 510(K)
- K884127LAKE N/G FEEDING TUBE2Cleared 510(K)
- K884275FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT2Cleared 510(K)
- K884309NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT2Cleared 510(K)
- K884128LAKE N/G EXTENSION SET2Cleared 510(K)
- K884439GASTROSTOMY FEEDING DEVICE2Cleared 510(K)
- K883319HILL NASOGASTRIC TUBE2Cleared 510(K)
- K882918KIM NASO-INTESTINAL TUBE2Cleared 510(K)
- K882682COMPAT ENTERAL DELIVERY SYSTEM2Cleared 510(K)
- K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE2Cleared 510(K)
- K882218COMPAT (R) ENTERAL DELIVERY SYSTEM2Cleared 510(K)
- K882089MRM GASTROSTOMY BELT2Cleared 510(K)
- K883336GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K883351PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K880767MIC NEEDLE JEJUNOSTOMY TUBE KIT2Cleared 510(K)
- K881978ENTERAL FEEDING TUBES2Cleared 510(K)
- K881162ENTERA* ENTERAL FEEDING BAG2Cleared 510(K)
- K875232INTRO-REDUCER (NASOGASTRIC TUBE)2Cleared 510(K)
- K881310DENT SLEEVE MANOMETRIC CATHETER2Cleared 510(K)
- K874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER2Cleared 510(K)
- K880768MIC (SPECIFIC LINE) REPLACEMENT KIT2Cleared 510(K)
- K880201REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #876002Cleared 510(K)
- K880051ENTERAL BAG/SET2Cleared 510(K)
- K874936MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY2Cleared 510(K)
- K875171J-CATH(TM)2Cleared 510(K)
- K874755EFFNER FE-EX* OROGASTRIC2Cleared 510(K)
- K873360ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG2Cleared 510(K)
- K880232NH REPLACEMENT GASTROSTOMY KIT2Cleared 510(K)
- K875126MIC (SPECIFIC LINE) INSERTION KIT2Cleared 510(K)
- K871848NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP2Cleared 510(K)
- K874393ENTERAL FEEDING TUBE2Cleared 510(K)
- K873343ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM2Cleared 510(K)
- K872921MSS ENTERAL DELIVERY SET2Cleared 510(K)
- K873441BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE2Cleared 510(K)
- K872771LOW PROFILE GASTROSTOMY2Cleared 510(K)
- K872932MOSS(R) MARK IV NASAL TUBES CAT.# 871682Cleared 510(K)
- K872531MIC MUSHROOM TIP GASTROSTOMY TUBE2Cleared 510(K)
- K871846FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM2Cleared 510(K)
- K872097INFANT FEEDING TUBE2Cleared 510(K)
- K872096INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT2Cleared 510(K)
- K871691MODIFIED MULTI-LUMEN NASOGASTRIC TUBE2Cleared 510(K)
- K871528ENTRIMIT GRAVITY FEEDING SET2Cleared 510(K)
- K871554MOSS(R) GASTROSTOMY TUBE CAT #5-177192Cleared 510(K)
- K871019ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET2Cleared 510(K)
- K871003ENTROSET-SW2Cleared 510(K)
- K870508GASTROINTESTINAL TUBE2Cleared 510(K)
- K864683NEONATAL FEEDING KIT2Cleared 510(K)
- K864364WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET2Cleared 510(K)
- K864218PROCON2Cleared 510(K)
- K861309JEJUNAL FEEDING TUBE2Cleared 510(K)
- K861323REPLACEMENT GASTROSTOMY TUBE2Cleared 510(K)
- K864182ENTERAL ADMINISTRATION ADAPTERS2Cleared 510(K)
- K862855CRAIG NASO-GASTRIC TUBE HOLDER2Cleared 510(K)
- K861599T-FASTENER2Cleared 510(K)
- K862573HOLLISTER DRAIN TUBE ATTACHMENT2Cleared 510(K)
- K862489ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE2Cleared 510(K)
- K861494EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML2Cleared 510(K)
- K862091MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE2Cleared 510(K)
- K861862DIETO CONTAINER FOR ENTERAL NUTRITION2Cleared 510(K)
- K861427ENTUBE TM, ENTERAL FEEDING TUBE2Cleared 510(K)
- K861618TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)2Cleared 510(K)
- K861090NUTRI-CATH - FEEDING TUBE2Cleared 510(K)
- K861552TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS2Cleared 510(K)
- K860818ONE TIME ENTERAL FEEDING BAG2Cleared 510(K)
- K860991SCLEROTHERAPY INJECTION CATHETER2Cleared 510(K)
- K855097COMPAT ENTERAL DELIVERY SYSTEMS2Cleared 510(K)
- K855098COMPAT ENTERAL DELIVERY SYSTEMS2Cleared 510(K)
- K860589INFLATOR/DEFLATOR PISTON SYRINGE2Cleared 510(K)
- K861051ISOLIFE DISPENSING SYSTEM2Cleared 510(K)
- K860285XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE2Cleared 510(K)
- K860052QWIK-CALL2Cleared 510(K)
- K860075DYNAFEED ENTERAL PUMP FEED BAG2Cleared 510(K)
- K854616ENTERAL FEEDING BAG2Cleared 510(K)
- K854660THE MMG ENTERAL FEEDING ADMINISTRATION SET2Cleared 510(K)
- K855121COLOSHIELD KIT2Cleared 510(K)
- K854215DYNAFEED2Cleared 510(K)
- K853384E-Z-EM GASTRIC LAVAGE CATHETER2Cleared 510(K)
- K853253CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI2Cleared 510(K)
- K85335388000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT2Cleared 510(K)
- K852552COONS GASTROSTICK SYSTEM2Cleared 510(K)
- K852535E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY2Cleared 510(K)
- K853288FEEDING UNITS & TUBES2Cleared 510(K)
- K851975ENTERAL FEEDING BAG, 1000 ML, & TUBING SET2Cleared 510(K)
- K853309P.A. ENTERAL FEEDING BAG 11002Cleared 510(K)
- K852966ENTERAL FEEDING CONTAINER2Cleared 510(K)
- K853197MIC JEJUNAL FEEDING TUBE2Cleared 510(K)
- K852707GASTRO-ENTEROSTOMY TUBE2Cleared 510(K)
- K852363MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT2Cleared 510(K)
- K852792CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW2Cleared 510(K)
- K851672NYHUS/NELSON TUBE2Cleared 510(K)
- K850664ENDO-TUBE2Cleared 510(K)
- K851671GASTROINTESTINAL TUBE2Cleared 510(K)
- K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO2Cleared 510(K)
- K851444KEITH-A.R.V.2Cleared 510(K)
- K832170MUFFLER GAS-AIR VENT UNIT2Cleared 510(K)
- K850182IVAC KEOFEED II POLYURETHANE FEEDING TUBE2Cleared 510(K)
- K850134ENTRON ENTERAL FEEDING BAG2Cleared 510(K)
- K843939PEDIATRIC SIZE K-TUBE A OR B2Cleared 510(K)
- K843567KANGAROO NASOGASTRIC FEEDING TUBE2Cleared 510(K)
- K844745K-TUBE2Cleared 510(K)
- K844789KANGAROO ACCESS II ENTERAL FEEDING CONTAINER2Cleared 510(K)
- K844203ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 4032Cleared 510(K)
- K844175ENTERNAL FEEDING TUBE-POLYURETHANE EF5042Cleared 510(K)
- K844174FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI2Cleared 510(K)
- K842174PERCUTANEOUS GASTROSTOMY TUBE2Cleared 510(K)
- K844222BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR2Cleared 510(K)
- K8439759 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE2Cleared 510(K)
- K842808URITROL-M2Cleared 510(K)
- K843392GAUDERER GASTROSTOMY BUTTON2Cleared 510(K)
- K843305DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP2Cleared 510(K)
- K841986PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG2Cleared 510(K)
- K842841VIVONEX TUNG STEN TIP TUBE2Cleared 510(K)
- K842589IVAC KEOFEED HYDROPHILIC FEEDING TUBE2Cleared 510(K)
- K842076MIC GASTROSTOMY TUBE2Cleared 510(K)
- K841945ENTERAL FEEDING BOTTLE2Cleared 510(K)
- K841349ESOPHAGEAL TUBE2Cleared 510(K)
- K841428JEJUNOSTOMY SET FOR TUBE FEEDING2Cleared 510(K)
- K841289RECTAL IRRIGATION TUBE2Cleared 510(K)
- K840864GORE-TEX CATHETER2Cleared 510(K)
- K841330GASTROSTOMY FEEDING TUBE2Cleared 510(K)
- K840752ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT2Cleared 510(K)
- K841014WEIGHTED FEEDING TUBE W/PRE-INSERTED2Cleared 510(K)
- K841038BLAKEMORE TUBE2Cleared 510(K)
- K841039CANTOR TUBE2Cleared 510(K)
- K841036RECTAL BALLOON CATHETERS2Cleared 510(K)
- K841035ULTRA BAKER JEJUNOSTOMY TUBE2Cleared 510(K)
- K841034DEAVER T-DRAIN & CATTEL T-DRAIN2Cleared 510(K)
- K841033MILLER-ABBOTT TUBE2Cleared 510(K)
- K840916DIETO CONTAINER FOR ENTERNAL NUTRIT2Cleared 510(K)
- K840656ENTERNAL Y EXTENSION SET RECORDER2Cleared 510(K)
- K840936NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT2Cleared 510(K)
- K833687DISPOS. ENTERIC FEEDING TUBES W/SAFE-T2Cleared 510(K)
- K834562ENTERNAL FEEDING TUBE2Cleared 510(K)
- K840019K-TUBE REPAIR KIT2Cleared 510(K)
- K834554ETHOX WEIGHTED FEEDING TUBE2Cleared 510(K)
- K834268ISLAMI GASTROINTESTINAL TUBE2Cleared 510(K)
- K834258HODGE DECOMPRESSION TUBE2Cleared 510(K)
- K833947SUPERIOR ENTERNAL FEEDING SYSTEM2Cleared 510(K)
- K832093FEEDING GASTROSTOMY TUBE2Cleared 510(K)
- K833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPY2Cleared 510(K)
- K833621ENTRI FLEX FEEDING TUBE2Cleared 510(K)
- K833591FEEDING TUBE2Cleared 510(K)
- K833513NEEDLE CATHETER JEJUNOSTOMY KIT2Cleared 510(K)
- K832859FOAM HELMET - USE W/ESOPHAGEAL TAMPONA2Cleared 510(K)
- K833293LEIDER FEEDING TUBE W/HYDROMER LUBR2Cleared 510(K)
- K832966FLEXIFLO ENTERAL FEEDING TUBE2Cleared 510(K)
- K833054GASTRIC SUMP TUBES2Cleared 510(K)
- K832927GRAVITY ENTERAL FEEDING SET2Cleared 510(K)
- K832196SHERIDAN/LEVI-A-SUMP2Cleared 510(K)
- K832672FOUR LUMEN BLAKEMORE TUBE2Cleared 510(K)
- K832293ENTERNAL FEEDING TUBE2Cleared 510(K)
- K831971VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE2Cleared 510(K)
- K831968VIVONEX TUNGSTEN TIP TUBE-BRAIDED2Cleared 510(K)
- K831969VIVONEX TUNGSTEN TIP TUBE-WOUND2Cleared 510(K)
- K832501ENEMA TUBE2Cleared 510(K)
- K831847JEJUNOSTOMY KIT2Cleared 510(K)
- K831840FEEDING TUBE PLACEMENT STYLET2Cleared 510(K)
- K831823AXIOM FEEDING GASTRO TUBE2Cleared 510(K)
- K831631GASTROSTOMY FEEDING SET2Cleared 510(K)
- K831328NEONATAL NASOGASTRIC FEEDING TUBE-2Cleared 510(K)
- K831970VIVONEX TUNGSTEN TIP TUBE-MONOFILA-2Cleared 510(K)
- K831974STOMACH TUBE LEVIN TUBE2Cleared 510(K)
- K831868DOBBHOFF FEEDING TUBE W/HYDROMER LUB2Cleared 510(K)
- K823475BROOKS SCLEROTHERAPY CUFF2Cleared 510(K)
- K831009CANTOR TUBE2Cleared 510(K)
- K830989BAKER JEJUNOSTOMY TUBE2Cleared 510(K)
- K830998MILLER-ABBOTT TUBE2Cleared 510(K)
- K830990BLAKEMORE TUBE2Cleared 510(K)
- K830987LEVIN TUBE2Cleared 510(K)
- K830986RECTAL TUBES2Cleared 510(K)
- K830985STOMACH TUBE2Cleared 510(K)
- K830794ARGYLE MADEN SILICONE GASTROSTOMY TUBE2Cleared 510(K)
- K831167ENTERAL PUMP SET2Cleared 510(K)
- K831168ENTERAL DELIVERY SET2Cleared 510(K)
- K831169TOP-FILL BAG2Cleared 510(K)
- K830965ENTERAL SOLUTION ADMIN. PUMP SET2Cleared 510(K)
- K830710ARGYLE SILICONE SALEM SUMP TUBE2Cleared 510(K)
- K830119NEEDLE CATHETER JEJUNOSTOMY KIT2Cleared 510(K)
- K823195GASTRIC LAVAGE KIT2Cleared 510(K)
- K822087DIA SCOPE2Cleared 510(K)
- K823082TRAVASORB NASOGASTRIC NASOINTESTINAL2Cleared 510(K)
- K822879ENTERAL NUTRITION 12Cleared 510(K)
- K822004FACE SHIELDS2Cleared 510(K)
- K822875PEDI-TUBE PEDIATRIC FEEDING TUBE2Cleared 510(K)
- K822565NEEDLE CATHETER JEJUNOSTOMY KIT2Cleared 510(K)
- K822380ROMBEAU GASTROSTOMY-JEJUNAL TUBE2Cleared 510(K)
- K822631ARGYLE DUO-TUBE2Cleared 510(K)
- K822228GASTRO VAGE SET FOR GASTRIC LAVAGE2Cleared 510(K)
- K822443NASO-GARD NASOGASTRIC TUBE HOLDER2Cleared 510(K)
- K821825CONPHAR SILICONE FEEDING TUBE2Cleared 510(K)
- K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP2Cleared 510(K)
- K821410CORPAK-MONITOR ENTERAL FEEDING CONTAIN2Cleared 510(K)
- K821409CORPAK-ENTERAL FEEDING CONTAINER2Cleared 510(K)
- K821231VIVONEX TUNGSTEN TIP TUBE PLACEMENT2Cleared 510(K)
- K821067VIVONEX ACUTROL ENTERNAL FEEDING SYS2Cleared 510(K)
- K821036ENTERNAL SOLUTION ADMIN. SET2Cleared 510(K)
- K813585WATERS ILEOSTOMY VALVE2Cleared 510(K)
- K820420AM. PH. STERILE FEEDING TUBE2Cleared 510(K)
- K820442ARGYLE INDWELL FEEDING TUBE2Cleared 510(K)
- K820441ARGYLE PVC FEEDING TUBE2Cleared 510(K)
- K820176VYGON ENTERNAL NUTRITION TUBES2Cleared 510(K)
- K813526FECAL SANITARY TUBE2Cleared 510(K)
- K813132THE CHICAGO GULLET2Cleared 510(K)
- K813169CELESTIN PULSION ESOPHOGEAL PROSTHESIS2Cleared 510(K)
- K812648EHTOX GASTRIC LAVAGE KIT #2050 & #20702Cleared 510(K)
- K812427CARTMILL/BARRY FEEDING TUBE2Cleared 510(K)
- K812507THE KEOFEED STOMACH TUBE2Cleared 510(K)
- K812102O.N.A.T.2Cleared 510(K)
- K812279ENTER-A1 ENTERIC FEEDING TUBE2Cleared 510(K)
- K811968VIVONEX TUNGSTEN TIP2Cleared 510(K)
- K811683ENTRI ENTERNAL FEEDING SET2Cleared 510(K)
- K811533MGN FEEDING TUBE2Cleared 510(K)
- K811639ETHIX FEEDING TUBES POLYURETHANE/RADIOP.2Cleared 510(K)
- K811061AUTOMATED GASTRIC LAVAGE2Cleared 510(K)
- K810979ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT2Cleared 510(K)
- K810996ENTERNAL PUMP SET W/INTEGRAL CONTAINER2Cleared 510(K)
- K810573TUBE FEEDING SET2Cleared 510(K)
- K810854KANGAROO NASOGASTRIC FEEDING TUBE2Cleared 510(K)
- K810250TRAY, IRRIGATION2Cleared 510(K)
- K810392OESOPHAGEAL THERAPY KIT2Cleared 510(K)
- K810499PERCUTANEOUS GASTROINTESTINAL TUBE2Cleared 510(K)
- K810156ARGYLE SALEM SUMP TUBE2Cleared 510(K)
- K802585FEEDING TUBES IN SILICONE 5,6,8&10 SIZES2Cleared 510(K)
- K802482KEOFEED (R) EASY-FILL ENTERIC FEED BAG2Cleared 510(K)
- K802300VIVONEX JEJUNOSTOMY KIT2Cleared 510(K)
- K801558ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.2Cleared 510(K)
- K801511NASO-GARD NASOGASTRIC TUBE HOLDER2Cleared 510(K)
- K801498ENTRI NASOGASTRIC FEEDING TUBE2Cleared 510(K)
- K800918MODIFIED FEEDING JEJUNOSTOMY TUBE2Cleared 510(K)
- K800815ENTERAL & NASOGASTRIC SOL. ADMIN. SET2Cleared 510(K)
- K800955TUBE FEEDING CONTAINER 1500 ML DISPOSE.2Cleared 510(K)
- K800510RECTAL & HARRIS FLUSH TUBES2Cleared 510(K)
- K800508STOMACH TUBES2Cleared 510(K)
- K800507FEEDING TUBES2Cleared 510(K)
- K792597RECTAL LEAKAGE INHIBITOR2Cleared 510(K)
- K792333BAKER INTESTINAL TUBE, TWIN CUFF2Cleared 510(K)
- K791714SURGIFEED2Cleared 510(K)
- K791758CLINIFEEDING SYSTEM 12Cleared 510(K)
- K791269CONPHAR STOMACH TUBE-STERILE2Cleared 510(K)
- K791268CONPHAR RECTAL TUBE-STERILE2Cleared 510(K)
- K791257CONPHAR FEEDING TUBE-STERILE2Cleared 510(K)
- K791250CONPHAR STOMACH TUBE-STERILE-X-RAY2Cleared 510(K)
- K790612NUTRIFLOW NASOGASTRIC FEEDING TUBE2Cleared 510(K)
- K790387FEEDING TUBE W/ LUBRICANT COATING2Cleared 510(K)
- K781230GAVAGE ADMIN. SET2Cleared 510(K)
- K760945SILASTIC PERCUTANEOUS GASTROINTEST. TUBE2Cleared 510(K)
- K760708SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE2Cleared 510(K)
- 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
- 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
Gastrointestinal Boundary Identifier (GIBI HD)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221898
- 510(k) Type
- Special
- Applicant
- ReShape Lifesciences
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/28/2022
- Days to Decision
- 28 days
- Submission Type
- Summary