meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
37
Latest Decision
1983-09-12

Clearances · page 102 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K832293 ENTERNAL FEEDING TUBE Concept, Inc. KNT Class II 1983-09-12
K831969 VIVONEX TUNGSTEN TIP TUBE-WOUND Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1983-09-01
K831968 VIVONEX TUNGSTEN TIP TUBE-BRAIDED Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1983-09-01
K831971 VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1983-09-01
K832501 ENEMA TUBE Cone Instruments, Inc. KNT Class II 1983-08-31
K831847 JEJUNOSTOMY KIT Accu-Line KNT Class II 1983-08-31
K832299 VISI-FLOW IRRIGATOR Convatec, A Division of E.R. Squibb & Sons EXD Class II 1983-08-26
K831029 HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. FLD Class II 1983-08-26
K832252 CLIRANS TAF06 HOLLOW FIBER DIALYZER Terumo Medical Corp. KOC Class II 1983-08-26
K831840 FEEDING TUBE PLACEMENT STYLET Biosearch Medical Products, Inc. KNT Class II 1983-08-12
K831631 GASTROSTOMY FEEDING SET Plasco, Inc. KNT Class II 1983-08-12
K831823 AXIOM FEEDING GASTRO TUBE Axiom Medical, Inc. KNT Class II 1983-08-12
K832103 BLOOD TUBING SET Lee Medical Intl., Inc. KOC Class II 1983-08-12
K831689 EMPTY DIALYSATE CONTAINER Delmed, Inc. FKK Class I 1983-08-11
K831857 SURGITEK PERCUTANEOUS ARNEGRADE SILITEK Medical Engineering Corp. FAD Class II 1983-08-11
K831622 MORHEL CLOSED URINARY DRAINAGE SET Morhel Mexicana KNX Class II 1983-08-11
K832007 PENTAX FG-34JA GASTROFIBERSCOPE Pentax Precision Instrument Corp. FDS Class II 1983-08-11
K831567 FOLEY-TEMP Mallinckrodt Critical Care KOD Class II 1983-08-10
K831660 AMS MALLEABLE PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 1983-08-08
K831132 COMPUDIAL/KP-1 Computer Dialysis Systems, Inc. LIF Class II 1983-08-08
K831796 URINE BAG SYSTEM I M, Inc. KNX Class II 1983-08-08
K831940 GAMMA STERILIZED CAPILLARY FLOW DIALYZ Travenol Laboratories, S.A. FKQ Class II 1983-08-08
K832165 IMPROVED SILICATH SILICONE ELASTOMER Travenol Laboratories, S.A. KOD Class II 1983-08-08
K831402 PRESSURE MONITOR & CONTROL UNIT APC-02A Parker Hannifin Corp. KXM Class II 1983-08-08
K832006 PENTAX FD-34A DUODENOFIBERSCOPE Pentax Precision Instrument Corp. FDT Class II 1983-08-01
K831384 COAXIAL BALLOON URETHRAL DILATOR Thomas J. Fogarty, M.D. FAH Class II 1983-07-26
K832106 EXTERNAL INCONTINENCE CATHETER TRAVEL Plasco, Inc. KNX Class II 1983-07-19
K832107 LEG BAG EXTENTION TUBE-STERILE Plasco, Inc. KNX Class II 1983-07-19
K831328 NEONATAL NASOGASTRIC FEEDING TUBE- Corpak Medsystems KNT Class II 1983-07-19
K831953 INFUSION PUMP Cryosan, Inc. FIR Class II 1983-07-19
K830841 COLOSTOMY BAG C & D Colostomy Pad Corp. EXB Class I 1983-07-19
K831970 VIVONEX TUNGSTEN TIP TUBE-MONOFILA- Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1983-07-18
K832009 MODEL #27224P CONTINUOUS FLOW PUMP KARL STORZ Endoscopy-America, Inc. OCX Class II 1983-07-18
K832108 EXTERNAL INCONTINENCE CATHETER SET-NON Plasco, Inc. KNX Class II 1983-07-18
K832109 EXTERNAL INCONTINENCE CATHETER TAKE-HOME Plasco, Inc. KNX Class II 1983-07-18
K831974 STOMACH TUBE LEVIN TUBE Medline Industries, Inc. KNT Class II 1983-07-18
K831868 DOBBHOFF FEEDING TUBE W/HYDROMER LUB Biosearch Medical Products, Inc. KNT Class II 1983-07-12
K823475 BROOKS SCLEROTHERAPY CUFF Inmed Corp. KNT Class II 1983-07-12
K831801 HEMOCLAV VENOUS CATHETER Exo, Inc. FIQ Class II 1983-07-07
K831828 TEFLON FEMORAL CATHETER MWI 100,10 & Med-West, Inc. LFK Class II 1983-07-07
K831770 ARTIFICIAL KIDNEY BLOOD CIRCUIT Eiken Kizai Co., Ltd. KOC Class II 1983-07-07
K831747 PLASMA THERAPY TUBESET-E100 SERIES Parker Hannifin Corp. FJK Class II 1983-06-30
K830722 SPORIDIDIN-D COLD STERILIZING/SOLUTION Sporicidin Intl. LIF Class II 1983-06-30
K831409 HAEMOLYTE SOLUTION Dialysis Clinic, Inc. KOC Class II 1983-06-30
K831606 GF-180-L HOLLOW FIBER HEMODIALYSIS Gambro, Inc. KOC Class II 1983-06-24
K831716 CAPD - CATHETER ADAPTER American Mcgaw FKX Class II 1983-06-24
K831446 SURGITEK NEPHROSTENT KIT Mec/Surgitek Products FAD Class II 1983-06-22
K831244 URETERAL STONE EXTRACTOR CATHETER American Edwards Laboratories KOD Class II 1983-06-17
K830719 UNIVERSAL CANNULA Acufex Microsurgical, Inc. GCJ Class II 1983-06-16
K831553 LEG DRAINAGE BAG STRAP BK6011 Fred Sammons, Inc. KNX Class II 1983-06-16
K830908 BICARBONATE/VARIABLE SODIUM KIT-DM-367 Extracorporeal Medical Specialities, Inc. FKQ Class II 1983-06-08
K831482 CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & Terumo Medical Corp. KOC Class II 1983-06-03
K831412 CRM-100 COLOR VIDEO CAMERA Umi, Inc. FET Class II 1983-06-03
K831376 CDS 2001 ARTIFICIAL KIDNEY Elmar Medical Systems, Ltd. KOC Class II 1983-06-03
K831440 SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 Med-West, Inc. FIQ Class II 1983-06-03
K831401 SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS Med-West, Inc. FIQ Class II 1983-06-03
K830990 BLAKEMORE TUBE Medovations, Inc. KNT Class II 1983-06-02
K830881 AMPERCIDE DISINFECTANT ACCESSORY TO - American Medical Products, Inc. FKX Class II 1983-06-02
K831433 EXTRASENSR ULTRAFILTRATION MONITOR Extracorporeal Medical Specialities, Inc. KOC Class II 1983-06-02
K830998 MILLER-ABBOTT TUBE Medovations, Inc. KNT Class II 1983-06-02
K830989 BAKER JEJUNOSTOMY TUBE Medovations, Inc. KNT Class II 1983-06-02
K831009 CANTOR TUBE Medovations, Inc. KNT Class II 1983-06-02
K830991 ESOPHAGEAL BOUGIES Medovations, Inc. KNQ Class II 1983-06-02
K831347 MICROCAPILLARY INFUSION SYSTEM J.S. Biomedicals, Inc. FFX Class II 1983-06-02
K830084 ANGIOSCOPE Trimedyne, Inc. LYK Class II 1983-06-02
K830354 COLORECTAL DILATOR Cleveland Medical Supply & Services FFP Class I 1983-05-27
K830987 LEVIN TUBE Medovations, Inc. KNT Class II 1983-05-27
K830994 REDOX CONTROLLER St. Louis Univ. Medical Center KDN Class II 1983-05-27
K830986 RECTAL TUBES Medovations, Inc. KNT Class II 1983-05-27
K823487 BARD URETERAL STENT C.R. Bard, Inc. FAD Class II 1983-05-27
K830190 AHR-3000 RE-USE ADAPTOR Colorado Medical, Inc. LIF Class II 1983-05-27
K831338 LUNDIA 10-3-L PARALLEL FLOW DIALYZER Gambro, Inc. KOC Class II 1983-05-27
K830985 STOMACH TUBE Medovations, Inc. KNT Class II 1983-05-27
K831369 LATEX URINARY CATHETERS Wayne Surgical Products KOD Class II 1983-05-27
K830546 DOSIMETRIC RELEASE American Hospital Supply Corp. KQT Class II 1983-05-25
K830786 DISIMETRIC RELEASE OF INSTRANETICS RAD American Convertors Div., American Pharmaseal KOA Class I 1983-05-18
K830674 MAHURKAR FEMORAL CATHETER Quinton, Inc. LFK Class II 1983-05-18
K830794 ARGYLE MADEN SILICONE GASTROSTOMY TUBE Sherwood Medical Co. KNT Class II 1983-05-18
K831317 BIOPSY ATTACHMENT Diasonics, Inc. FCI Class II 1983-05-18
K830884 SURGITEKS PERCUTANEOUS ANTEGRADE ALL - Medical Engineering Corp. FAD Class II 1983-05-09
K831168 ENTERAL DELIVERY SET Biosearch Medical Products, Inc. KNT Class II 1983-05-09
K822085 PRO-SCOPE Exitec, Inc. FER Class II 1983-05-09
K831167 ENTERAL PUMP SET Biosearch Medical Products, Inc. KNT Class II 1983-05-09
K830595 MONITRAL Hospal Medical Corp. KDI Class II 1983-04-28
K830802 LOOP RETRIEVER Van-Tec, Inc. OCZ Class II 1983-04-28
K831121 CURITY LEG BAG The Kendal Co. KNX Class II 1983-04-28
K830811 ASEPTIC FLUID TRANSFER SYSTEM Steridoc Corp. KQQ Class II 1983-04-28
K831169 TOP-FILL BAG Biosearch Medical Products, Inc. KNT Class II 1983-04-28
K830487 HEMO-PROCESSING SYSTEM Sartorius Filters, Inc. KDI Class II 1983-04-28
K830946 MALE EXTERNAL CATHETER Post Medical, Inc. KNX Class II 1983-04-28
K830596 ULTRAFILTRATION MONITOR UFM-10-2 Gambro, Inc. KDI Class II 1983-04-27
K830965 ENTERAL SOLUTION ADMIN. PUMP SET Corpak Co. KNT Class II 1983-04-18
K830924 CRM-114 COLOR VIDEO CAMERA Umi, Inc. FET Class II 1983-04-18
K830917 SURGITEK SIZER FOR PENILE PROSTHESIS Medical Engineering Corp. FAE Class II 1983-04-12
K830048 INFLATABLE PENILE PROSTH. - CYLINDER American Medical Systems, Inc. FAE Class II 1983-04-12
K830677 BLOOD LINE SETS FOR HEMOFILTRATION Gambro, Inc. FJK Class II 1983-04-12
K830818 ASAHI BLOOD/PLASMA PUMP #ABP-01A & Parker Hannifin Corp. FIR Class II 1983-04-12
K830945 SUR-FIT FLEXIBLE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1983-04-12
K830840 OPEN ENDED URETERAL CATHETER Van-Tec, Inc. GBM Class II 1983-04-06
K830905 LUNDIA 10-2-N PARALLEL FLOW DIALYZER Gambro, Inc. KOC Class II 1983-04-06

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