meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
43
Latest Decision
1980-10-31

Clearances · page 108 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802482 KEOFEED (R) EASY-FILL ENTERIC FEED BAG Health Development Corp. KNT Class II 1980-10-31
K802009 FLOWCLAMP CAT.#1011 & 1012 Pollak (Intl.), Ltd. FKK Class I 1980-10-31
K802516 FOLEY CATHETER Abco Dealers, Inc. KOD Class II 1980-10-31
K802606 LEG BAG EXTENSION TUBE Associated Medical Products Co. KNX Class II 1980-10-31
K802300 VIVONEX JEJUNOSTOMY KIT Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1980-10-23
K802444 PAPILLOTOME PRODUCT Mill-Rose Laboratory KNS Class II 1980-10-23
K801818 TENCKHOFF CATHETER Sil-Med Corp. FJS Class II 1980-10-23
K802443 E.R.C.P. CANNULA PRODUCT Mill-Rose Laboratory ODD Class II 1980-10-23
K801785 URETHRAL CATHETERIZATION TRAYS The Healthcare Group Laboratories, Inc. KOD Class II 1980-10-21
K801787 URINARY CATHETER CARE TRAYS #3700&3710 The Healthcare Group Laboratories, Inc. KOD Class II 1980-10-21
K801820 FOLEY CATHETERIZATION TRAY Abco Dealers, Inc. KOD Class II 1980-10-21
K801881 INPERSOL-CAPD ADMINISTRATION SET Abbott Laboratories KDJ Class II 1980-10-10
K801679 BETA-CAP II Quinton, Inc. FJS Class II 1980-10-03
K801786 URINE COLLECTION CONTAINERS, #3600 &3610 The Healthcare Group Laboratories, Inc. KOD Class II 1980-09-30
K801826 RENAFLO HOLLOW FIBER DIALYZERS #MP 140 Renal Systems, Inc. FJI Class II 1980-09-26
K801967 MEDCOMP FEMORAL VEIN CATHETER Medical Components, Inc. FIF Class II 1980-09-26
K801451 ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM Medical, Inc. FJG Class II 1980-09-26
K801968 HEMOCATH I KIDNEY DIALYSIS CATHETER Medical Components, Inc. LBW Class II 1980-09-26
K802173 URIHESIVE STRIPS E. R. Squibb & Sons, Inc. KNX Class II 1980-09-26
K801966 HEMO-CATH II KIDNEY DIALYSIS CATHETER Medical Components, Inc. FIE Class II 1980-09-26
K802172 URIHESIVE SYSTEM E. R. Squibb & Sons, Inc. KNX Class II 1980-09-26
K801825 RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. Renal Systems, Inc. FJI Class II 1980-09-26
K801899 KEITHLEY LYMPHOCYTE DEPLETION CART Keithley Development Co. KDK Class II 1980-09-26
K801827 RENAFLO HOLLOW FIBER DIALYZER #100.1 Renal Systems, Inc. FJI Class II 1980-09-26
K802007 PEDIWET=GUAZE IMPREGNATED WITH PETROL Pollak (Intl.), Ltd. FRQ Class II 1980-09-26
K802083 CATHETER INSERTION TRAY Walpak Co. KOD Class II 1980-09-16
K802075 HOLLOW FIBER DIALYZER HOLDER Renal Devices, Inc. FKI Class II 1980-09-16
K801703 SUR-FIT SYSTEM STERILE O.R. SETS E. R. Squibb & Sons, Inc. EXB Class I 1980-09-09
K802012 TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 Pollak (Intl.), Ltd. KNX Class II 1980-09-09
K792724 AMS MALLEABLE OR JONAS SILICONE-SILVER American Medical Systems, Inc. FAE Class II 1980-09-09
K801757 MMI/GAELTEC CATHETER TIP PRESS. TRANSDU Medical Measurements, Inc. FES Class II 1980-08-27
K801702 SUR-FIT SYSTEM PRE-OPERATION SET E. R. Squibb & Sons, Inc. EXB Class I 1980-08-27
K801480 GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ Gambro, Inc. KDI Class II 1980-08-27
K801479 GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- Gambro, Inc. KDI Class II 1980-08-27
K801478 SSC8 SORENSON SUBCLAVIAN CATHETER Sorensen Research FIQ Class II 1980-08-27
K801377 CYBER 120 HEMODIALYZER Cyberex Corp. FJG Class II 1980-08-27
K801415 LATEX FOLEY CATHETER (HYDROMER COATED) G.D. Searle and Co. KOD Class II 1980-08-20
K801503 HOLLISTER KARAYA SEAL RING Hollister, Inc. EXB Class I 1980-08-13
K801782 GENERAL PURPOSE IRRIGATING/ASPIR SYR. The Healthcare Group Laboratories, Inc. KQT Class II 1980-08-13
K801618 ARGYLE A-V MEDI-WING HEMODIALYSIS SET Sherwood Medical Co. FIE Class II 1980-08-13
K801711 BK-6010 CATHETER TUBE HOLDER Fred Sammons, Inc. KNX Class II 1980-08-13
K801783 CATHETER IRRIGATION TRAYS, #3300, 3310 & The Healthcare Group Laboratories, Inc. EYN Class II 1980-08-13
K801723 UR 150-UR 150T Siemens Corp. KQS Class I 1980-08-13
K801731 C-DAK DUO-FLUX ARTIFICIAL KIDNEY Cordis Corp. KDI Class II 1980-08-13
K801784 URINARY CATHETERS #3400,3410 &3420 The Healthcare Group Laboratories, Inc. KOD Class II 1980-08-13
K801781 CATHETER IRRIGATION SYRINGES, #3100,3110 The Healthcare Group Laboratories, Inc. KQT Class II 1980-08-13
K801629 COVER-ALL MALE INCONTINENCE DEVICE The Urology Group KNX Class II 1980-08-12
K801504 HOLLISTER DRAINAGE POUCH Hollister, Inc. FON Class I 1980-08-12
K800993 INPERSOL CAPD ADMIN. SET & CATHETER ADAP Abbott Laboratories KDJ Class II 1980-08-12
K801193 CLIRANS TE15 HOLLOW FIBER DIALYZER Terumo America, Inc. KDJ Class II 1980-08-12
K801194 CLIRANS TE07 HOLLOW FIBER DIALYZER Terumo America, Inc. FJI Class II 1980-08-12
K801192 CLIRANS TE10 HOLLOW FIBER DIALYZER Terumo America, Inc. FJI Class II 1980-08-12
K801220 PERITONEAL DIALYSIS CYCLER SET W/PUMP American Medical Products, Inc. KDJ Class II 1980-08-12
K800536 MODEL H 607-.67M2 30 MICRON RP AN69 MEM Hospal Medical Corp. KDI Class II 1980-08-07
K801632 THE BELLCO FISTULA NEEDLES Bellco Artifidial Organ Spec., Inc. FIE Class II 1980-08-04
K801273 MAGILL CATHETER INTRO. FORCEPS J. Sklar Mfg. Co., Inc. KOA Class I 1980-07-28
K801471 SUPER BANISH DEODORANT Howmedica Corp. EXB Class I 1980-07-28
K801247 CCD ENDOSCOPE AND ATTACHMENTS Welch Allyn, Inc. GCP Class II 1980-07-28
K801021 URINEBAG Unovex of Denmark KNX Class II 1980-07-28
K801522 ARGYLE RIGID URINE MEASURING/COLL. DEV. Sherwood Medical Co. KNX Class II 1980-07-28
K800918 MODIFIED FEEDING JEJUNOSTOMY TUBE Mitchell V. Kaminski, Jr., M.D. KNT Class II 1980-07-28
K801558 ENTERIC FEEDING TUBE W/SEGM. FLEX. WT. Biosearch Medical Products, Inc. KNT Class II 1980-07-28
K801511 NASO-GARD NASOGASTRIC TUBE HOLDER Howmedica Corp. KNT Class II 1980-07-28
K801303 MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST Western Laboratories Corp. KDI Class II 1980-07-28
K801498 ENTRI NASOGASTRIC FEEDING TUBE Biosearch Medical Products, Inc. KNT Class II 1980-07-28
K801178 COBE HF80, CAT. #18-580 Cobe Laboratories, Inc. FJI Class II 1980-07-28
K800496 CYCLER W/5 OR 10 HR. FILL/DWELL TIMER American Medical Products, Inc. KPF Class II 1980-07-21
K801370 GF-120-L DIALYZER Gambro, Inc. FJI Class II 1980-07-21
K801385 K1 POTASSIUM ACETATE ADDITIVE Organon Teknika Corp. FKT Class II 1980-07-21
K801440 SORB 10 DIALYSATE INFUSATE C1 INFUSATE Organon Teknika Corp. FKT Class II 1980-07-21
K801344 EXTRACORPOREALS' ALTERNATE MEMBRANE Extracorporeal Medical Specialities, Inc. FJI Class II 1980-07-21
K800815 ENTERAL & NASOGASTRIC SOL. ADMIN. SET G.D. Searle and Co. KNT Class II 1980-07-21
K800624 LOW-ACETATE HEMODIALYSIS BATH CONCENTR. Travenol Laboratories, S.A. KPO Class II 1980-07-14
K801211 COBE HEMOFLO BLOOD TUBING SETS Cobe Laboratories, Inc. FJK Class II 1980-07-14
K801355 BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR Cordis Corp. KOC Class II 1980-07-08
K801356 BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET Cordis Corp. KOC Class II 1980-07-08
K801354 BIONICS ARTERIAL/VENOUS FISTULA NEEDLE Cordis Corp. KOC Class II 1980-07-08
K801352 HEMORRHOIDAL LIGATION INSTR. SYSTEM Depuy, Inc. FHN Class II 1980-07-08
K801045 GF120H DIALYZER Gambro, Inc. FJI Class II 1980-06-30
K800565 HESSLER COLON THERAPY DEVICE Hessler Mfg. Co. KPL Class II 1980-06-26
K800890 LINEBERGER EXTERNAL MALE CATHETER Lineberger External Catheter Co. KNX Class II 1980-06-20
K800822 CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE Kli FAP Class II 1980-06-17
K801223 PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A Pentax Precision Instrument Corp. FDF Class II 1980-06-09
K801144 ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS Ethox Corp. FHT Class II 1980-06-09
K800955 TUBE FEEDING CONTAINER 1500 ML DISPOSE. The Healthcare Group Laboratories, Inc. KNT Class II 1980-05-30
K800694 MMG DISPOSABLE URINARY LEG BAG Medical Marketing Group KNX Class II 1980-05-30
K800915 JOHNLOZ ENDOSCOPY HANDLE Endoscopic Surgical Accessories, Inc. KNS Class II 1980-05-30
K801016 GAMBRO G SERIES BLOOD LINE SETS FOR HEM. Gambro, Inc. FJK Class II 1980-05-30
K800771 MOD. DM-356 IPS INTERFACE MODULE Extracorporeal Medical Specialities, Inc. FKQ Class II 1980-05-20
K800961 ENEMA CONTAINER DISP. FOR EMEMA ADMIN. The Healthcare Group Laboratories, Inc. FCE Class I 1980-05-14
K800960 1500 ML DISPOSABLE ENEMA CONTAINER(1110) The Healthcare Group Laboratories, Inc. FCE Class I 1980-05-14
K800772 MOD. DM-357 BICARBONATE RETROFIT KIT Extracorporeal Medical Specialities, Inc. FKR Class II 1980-05-14
K800913 GYNECOLOGICAL CYSTO/URETHROSCOPE Kli FGC Class II 1980-05-14
K800959 LARGE VOLUME ENEMA CONTAINER DISPOSABLE The Healthcare Group Laboratories, Inc. FCE Class I 1980-05-14
K800723 MICRO-COIL 100 COIL DIALYZER Erika, Inc. FHS Class II 1980-05-14
K800969 M.R. ASSOC. CANNULAS Mr Associates, Inc. OCZ Class II 1980-05-08
K800964 M.R. ASSOC. BALL TYPE COAGULATOR Mr Associates, Inc. KNS Class II 1980-05-08
K800972 M.R. ASSOC. TRIPOD GRASPING FORCEPS Mr Associates, Inc. OCZ Class II 1980-05-08
K800973 M.R. ASSOC. HOT BIOPSY FORCEPS Mr Associates, Inc. KNS Class II 1980-05-08
K800975 M.R. ASSOC. TRUE-FEEL HANDLE Mr Associates, Inc. KNS Class II 1980-05-08

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