meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
46
Latest Decision
1984-02-04

Clearances · page 101 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K834438 TEMPERATURE SENSING FOLEY CATHETER C.R. Bard, Inc. KOD Class II 1984-02-04
K833947 SUPERIOR ENTERNAL FEEDING SYSTEM Superior Plastic Products Corp. KNT Class II 1984-02-04
K833924 TWO CHANNEL GASTROFIBERSCOPE FG-36T Pentax Precision Instrument Corp. FDS Class II 1984-02-04
K834268 ISLAMI GASTROINTESTINAL TUBE Biosearch Medical Products, Inc. KNT Class II 1984-02-04
K833043 UROMETER Browne Medical, Inc. FFG Class II 1984-02-04
K834403 INJECTION NEEDLE Bobbs Medical, Inc. FBK Class II 1984-02-04
K834596 BLOOD TUBING Renal Systems, Inc. KOC Class II 1984-02-04
K833565 COMFEEL PASTE Coloplast A/S EXB Class I 1984-01-30
K833570 COLOPLAST BABY URINE COLLECTORS Coloplast A/S KNX Class II 1984-01-30
K833571 STERILE DRAINAGE SYSTEM Coloplast A/S EXB Class I 1984-01-30
K833719 PREPACELL THIN NEEDLE ASPIRATION TRAY Applied Medical Devices, Inc. KOD Class II 1984-01-25
K831530 PLASTIC LEG BAG Forever-Dry, Inc. KNX Class II 1984-01-03
K833859 TAMPONADE BALLOON CUFF American Endoscopy, Inc. GCP Class II 1984-01-03
K833906 NEGATIVE PRESSURE VENOUS BLOOD LINE Erika, Inc. KOC Class II 1984-01-03
K832960 SHUFFIELD TECH ENEMA TIP Shuffield Tech Co. FCE Class I 1984-01-03
K832547 ULTRAFILTRATION CONTROLLER Extracorporeal Medical Specialities, Inc. KDI Class II 1984-01-03
K833905 NEGATIVE PRESSURE ARTERIAL BLOOD Erika, Inc. KOC Class II 1984-01-03
K833937 UMI PERCUTANEOUS TRANSHEPATIC CHOLAN Universal Medical Instrument Corp. FGE Class II 1984-01-03
K833896 BICARBOLYTE HEMO-DIAL Edlaw Pharmaceuticals, Inc. KOC Class II 1984-01-03
K833432 CATHETER INSERTION KIT Clinipad Corp. KOD Class II 1983-12-28
K832192 SUCTION-HEMORRHOID-LIGATOR Research Endoscope Systems Intl. FHN Class II 1983-12-27
K833860 TUCK-TITE COLON FLUID RETAINER Clayton Medical Products, Inc. FCE Class I 1983-12-27
K833569 COMFEEL BARRIER CREAM Coloplast A/S EXB Class I 1983-12-27
K833308 DUAL LUMEN NEEDLE Quinton, Inc. KOC Class II 1983-12-27
K833790 CURITY 100% SILICONE COUDE' CATHETER The Kendal Co. KOD Class II 1983-12-27
K833749 PERITONEAL CATHETER-CHANGES- Quinton, Inc. FKX Class II 1983-12-27
K833566 COMFEEL CLEANSER Coloplast A/S EXB Class I 1983-12-27
K832543 MALE THERAPEUTIC POTENT AID Mace'S Scientific LKY Class II 1983-12-27
K833920 KELLY CHOLANGIOCATH Perry, Div. FGE Class II 1983-12-27
K833139 ACUTE HEMODIALYSIS TRAYS Intermed, Inc. KNZ Class II 1983-12-22
K833252 ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF Erika, Inc. KOC Class II 1983-12-14
K833848 DUAL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1983-12-08
K832677 P-S MEDICAL BERLIN VISADUCT KIT Pudenz-Schulte Medical Research Corp. KOA Class I 1983-12-08
K833503 CLIRANS MODEL TAF 15 HOLLOW FIBER Terumo Medical Corp. KOC Class II 1983-12-08
K833440 BLOOD SAFETY MODULE BSM2 Hospal Medical Corp. KOC Class II 1983-12-08
K833622 RENALLOY HEMASITE VASCULAR ACCESS SHUNT Renal Systems, Inc. FIQ Class II 1983-11-29
K833492 PERCUTANEOUS ENDOSCOPIC GASTROSCOPY American Endoscopy, Inc. KNT Class II 1983-11-29
K833595 CAPD ULTRAVIOLET GERMICIDAL EXCHANGE Travenol Laboratories, S.A. FKX Class II 1983-11-29
K833124 HOBBS MEDICAL RETRIEVAL BASKET Hobbs Medical, Inc. OCZ Class II 1983-11-29
K832566 COAXIAL ELECTRODE #300A K-Med, Inc. FFK Class II 1983-11-28
K833065 AUTOMATIC PERITONEAL DIALYSIS CYCLER Travenol Laboratories, S.A. FKX Class II 1983-11-28
K832925 MODIFICATION IN MEMBRANE HOUSING CONFI Ries Biologicals KOC Class II 1983-11-28
K833621 ENTRI FLEX FEEDING TUBE Biosearch Medical Products, Inc. KNT Class II 1983-11-28
K833417 ENDOSCOPIC RETROGRADE Microvasive ODD Class II 1983-11-28
K833628 LUMEN-4 URODYNAMIC CATHETER Surgitek FAP Class II 1983-11-28
K832756 PRI A PUS Trans Texas Medical Devices Corp. LKY Class II 1983-11-28
K833189 HYDROFLOW SUCTION IRRIGATION SYSTEM Portex, Inc. GCJ Class II 1983-11-28
K833625 ACTIVE LIFE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1983-11-28
K833591 FEEDING TUBE Medovations, Inc. KNT Class II 1983-11-28
K833653 D-LYTE Dialysis Products, Inc. KOC Class II 1983-11-28
K833513 NEEDLE CATHETER JEJUNOSTOMY KIT Biosearch Medical Products, Inc. KNT Class II 1983-11-28
K833150 ASAHI HOLLOW FIBER KIDNEYS, EXCEL Asahi Medical Co., Ltd. KOC Class II 1983-11-15
K833330 MUTO BRUSH Microvasive FDX Class II 1983-11-14
K832859 FOAM HELMET - USE W/ESOPHAGEAL TAMPONA Inmed Corp. KNT Class II 1983-11-14
K833331 ASPIRATION & IRRIGATION CATHETER Microvasive OCX Class II 1983-11-14
K833061 C-FLEX PENROSE DRAINAGE TUBE Concept, Inc. FFA Class II 1983-11-07
K832866 HEMO-DIAL Cmi Pharmaceuticals, Inc. KPO Class II 1983-11-03
K832698 ANGIOSCOPY CATHETER American Edwards Laboratories LYK Class II 1983-11-03
K833245 SECURITY STRETCH BRIEF-MEDICAL Mb Products, Ltd. KNX Class II 1983-10-31
K833293 LEIDER FEEDING TUBE W/HYDROMER LUBR Biosearch Medical Products, Inc. KNT Class II 1983-10-31
K833125 HOBBS MEDICAL GRASPING FORCEPS Hobbs Medical, Inc. OCZ Class II 1983-10-31
K832966 FLEXIFLO ENTERAL FEEDING TUBE Abbott Laboratories KNT Class II 1983-10-31
K832869 MOTILITY MEASUREMENT SYS MMS-100 Narco Bio-Systems FFX Class II 1983-10-31
K833268 ENDOSCOPIC OVERTUBE Mill-Rose Laboratory FED Class II 1983-10-31
K833181 HPR HOME PATIENT RENATRON Renal Systems, Inc. LIF Class II 1983-10-27
K832043 SURGIKEK PENILE PROSTHESIS TAIL EXTEND Medical Engineering Corp. FAE Class II 1983-10-20
K832458 AUTOMATIC ENDOSCOPE American Endoscopy, Inc. NVE Class II 1983-10-20
K830667 SILICONE-SILVER PENILE PROSTHESIS-ESK Dacomed Corp. FTQ Class II 1983-10-20
K832807 PEDIATRIC ILLUMINATING URETERAL Van-Tec, Inc. FCW Class II 1983-10-19
K833242 DEFLECTING GUIDE WIRE Van-Tec, Inc. KNY Class II 1983-10-19
K833054 GASTRIC SUMP TUBES Medovations, Inc. KNT Class II 1983-10-19
K832822 CLOSED SYS. DRAINAGE BAGS & TRAYS Medline Industries, Inc. KNX Class II 1983-10-14
K832915 URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN Surgitek FAD Class II 1983-10-14
K832623 TOP DISPOS. INFUSION SET/HEMODIALY Top Surgical Manufacturers Co. KOC Class II 1983-10-14
K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 Extracorporeal Medical Specialities, Inc. FJK Class II 1983-10-14
K832808 URETERAL DILATION SET Van-Tec, Inc. EZN Class II 1983-10-14
K832196 SHERIDAN/LEVI-A-SUMP Sheridan Catheter Corp. KNT Class II 1983-10-14
K832141 MICROSTAR VC1 VOLUMETRIC CYCLER Medionics International , Ltd. FKX Class II 1983-10-14
K832136 DUAL FLOW NEEDLE Travenol Laboratories, S.A. FIE Class II 1983-10-14
K832450 URO-TEX MALE EXTERNAL CATHETER Sierra Laboratories, Inc. KNX Class II 1983-10-14
K832927 GRAVITY ENTERAL FEEDING SET Medical Connections KNT Class II 1983-10-14
K832666 NEPHROSS PRESTO Organon Teknika Corp. KOC Class II 1983-10-14
K832894 LUNDIA 10-2-L PARALLEL PLATE HEMODIALY Gambro, Inc. KOC Class II 1983-10-14
K832230 DIALYZER PREPARATION SYS DPS-4 Seratronics, Inc. LIF Class II 1983-10-14
K831766 MICROSTAR VCI Medionics International , Ltd. FKX Class II 1983-10-14
K832040 STERILE FLUID PRODUCING UNIT #EP550 American Cystocope Makers, Inc. LJH Class II 1983-09-29
K832053 SINGLE PATIENT SYS. II MODEL DM-450 Extracorporeal Medical Specialities, Inc. KOC Class II 1983-09-29
K831663 TISSUE FORCEPS Medcare Products KOC Class II 1983-09-26
K832645 BIOSPAL 3000 S Hospal Medical Corp. KDI Class II 1983-09-20
K832659 BIOSPAL 1200S Hospal Medical Corp. KDI Class II 1983-09-20
K832526 UROTRACK PLUS Vital Metrics, Inc. KNX Class II 1983-09-19
K832389 CATHETER CARE TRAY Inmed Corp. KOD Class II 1983-09-19
K832672 FOUR LUMEN BLAKEMORE TUBE Inmed Corp. KNT Class II 1983-09-12
K831788 URODYNAMIC ANALYZER C.R. Bard, Inc. FAN Class II 1983-09-12
K832692 CURITY CATHETER STRAP The Kendal Co. KOD Class II 1983-09-12
K831875 BALLOON DILATION HELICAL STONE EXTRACT Vpi FFL Class II 1983-09-12
K832489 CONVEEN DRIP COLLECTOR/NET PANTS Telcam Medical Devices, Inc. EYQ Class I 1983-09-12
K832537 CONVEEN LEG BAG W/TUBE-DRAINAGE BAG Telcam Medical Devices, Inc. KNX Class II 1983-09-12
K831743 STERILE FOLEY CATHETERS & UROLOGICAL Electromedics, Inc. KOD Class II 1983-09-12
K832663 GAMMA STERIL. CAPILLARY FLOW DIALY-G15 Travenol Laboratories, S.A. FKQ Class II 1983-09-12

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.