meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
1981-04-07

Clearances · page 107 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810710 HOLLISTER SKIN BARRIER B Hollister, Inc. EXB Class I 1981-04-07
K810249 TRAY, CATHERIZATION, URETHRAL Megaplast, Inc. KOD Class II 1981-04-07
K810682 PENTAX COLONOSCOPE MODEL FC-34LA Pentax Precision Instrument Corp. FDF Class II 1981-04-03
K810503 FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE Olympus Corp. NWS Class II 1981-04-03
K810392 OESOPHAGEAL THERAPY KIT Keymed, Inc. KNT Class II 1981-03-31
K810745 DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 Vas-Cath of Canada , Ltd. LFJ Class II 1981-03-31
K810791 PENTAX COLONOSCOPE MODEL FC-34 MA Pentax Precision Instrument Corp. FDF Class II 1981-03-31
K810630 SILICONE ELASTOMER COATED LATEX FOLEY G.D. Searle and Co. KOD Class II 1981-03-31
K810787 UROLOGIC TUBE HOLDER The Urology Group OCV Class II 1981-03-31
K810654 STOPPERLESS HOT/COLD RUBBER WATER BOTTLE First Industries, Inc. FDF Class II 1981-03-27
K810114 VASCULAR ACCESS SYSTEM Bentley Laboratories, Inc. FIQ Class II 1981-03-26
K810671 CCPD 3 LITER DRAINAGE SET American Medical Products, Inc. KDJ Class II 1981-03-24
K810670 CCPD CYCLER SET American Medical Products, Inc. KDJ Class II 1981-03-24
K810600 CAPD EXCHANGE SET American Mcgaw KDJ Class II 1981-03-24
K810368 VANCE PERCUTANEOUS MALECOT NEPHROSTOMY Vance Products, Inc. KOB Class II 1981-03-20
K802478 CYBER 120 HEMODIALYZER Cyberex Corp. FJG Class II 1981-03-20
K810336 POLYPECTOMY SNARE Medi-Tech, Inc. KNS Class II 1981-03-20
K810371 VANCE URETHAL DILATOR SET Vance Products, Inc. KOE Class II 1981-03-20
K810367 KISH URETHRAL ILLUMINATED CATHETER SET Vance Products, Inc. KOD Class II 1981-03-20
K810370 POLLACK CHAIN CYSOURETHROGRAM SET Vance Products, Inc. FGI Class II 1981-03-20
K810315 ALTERNATE STERILIZ. FOR CELLULOSE ACET Cordis Corp. FKQ Class II 1981-03-20
K810372 VANCE DEFLECTABLE BIOPSY BRUSH SET Vance Products, Inc. KOD Class II 1981-03-20
K810257 VESSEL TIPS, SIZES 13-18 Quinton, Inc. FKW Class II 1981-03-13
K810480 SCANLAN SUTURE BOOTS Scanlan Intl., Inc. KOC Class II 1981-03-13
K810236 MIROMED PERITONEAL DIALYSIS CATHETER American Medical Products, Inc. FJS Class II 1981-03-13
K810691 CURITY 100% SILICONE IRRIGATION FOLEY The Kendal Co. EZL Class II 1981-03-13
K803275 KPP PERITONEAL DIALYSATE FILTER Millipore Corp. KPP Class II 1981-03-13
K810533 CIRCLE NEPHROSTOMY TUBE INTRODUCER American V. Mueller KOA Class I 1981-03-11
K810544 INCONTINENT PAD & BELT Principle Business Ent. EYQ Class I 1981-03-11
K803068 NIKKISO ND-14 PARALLEL FLOW DIALYZER NIKKISO CO., LTD. FJG Class II 1981-03-04
K810074 ACCUFLO 100 Renal Care Corp. KOC Class II 1981-03-04
K810499 PERCUTANEOUS GASTROINTESTINAL TUBE Health Development Corp. KNT Class II 1981-03-04
K810156 ARGYLE SALEM SUMP TUBE Sherwood Medical Co. KNT Class II 1981-03-02
K810393 ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. Keymed, Inc. FET Class II 1981-03-02
K810131 ADMINISTRATION SET G.D. Searle and Co. FPD Class II 1981-02-26
K810127 GAMBRO BICARBONATE MODULE, BCM-10 Gambro, Inc. FKR Class II 1981-02-25
K810281 UROLOGICAL CATHETERS Latex Ind., Inc. KOD Class II 1981-02-25
K810227 MODEL #53110 DISPOSABLE ANOSCOPE Welch Allyn, Inc. FER Class II 1981-02-19
K810280 DIALYSATE CONCENTRATE FOR HEMODIALYSIS Cobe Laboratories, Inc. KPO Class II 1981-02-19
K802894 CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY Cordis Corp. FJI Class II 1981-02-19
K802893 CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY Cordis Corp. FJI Class II 1981-02-13
K810216 ARGYLE ROB-NELS Sherwood Medical Co. KOD Class II 1981-02-09
K810180 WILLIAMS OESOPHAGEAL VARICES INJECT TUBE Keymed, Inc. FED Class II 1981-02-09
K802364 EXTRACORPOREAL'S EXP 400 PARALLEL PLATE Extracorporeal Medical Specialities, Inc. FJG Class II 1981-01-29
K803300 INPERSOL CAPD BAG PORT CLAMP Abbott Laboratories KDJ Class II 1981-01-29
K810021 FLO-TEMP Laminar Flow Industries FLA Class II 1981-01-23
K803111 ERECTAID Burditt & Calkins-Siemens-Elema FAE Class II 1981-01-23
K802361 DIALYIS START CARE KIT Med-Pak Corp. FKG Class I 1981-01-16
K803214 ACMI BIPOLAR HEMOSTATIC ELECTRODE American Cystocope Makers, Inc. FEH Class II 1981-01-15
K810007 PENTAX UPPER G.I. FIBERSCOPE, #FG-34 Pentax Precision Instrument Corp. GDB Class II 1981-01-15
K803258 CORDIS HAKIM ASCITES VALVE SYSTEM Cordis Corp. KPM Class II 1981-01-15
K803259 CLOSED SYSTEM URETHRAL CATHETERIZ. SET Medical Devices, Inc. KOD Class II 1981-01-09
K803100 STOMAHESIVE PASTE PROTECTIVE SKIN BARR E. R. Squibb & Sons, Inc. EZR Class I 1981-01-08
K803062 CATH-SECURE Melissa C. Johnson KOD Class II 1981-01-07
K802613 C-PAK MODEL 12 ARTIFICIAL KIDNEY Cordis Corp. FJI Class II 1981-01-07
K802878 K-KATH URETHRAL CATHETER INTRODUCER B&K Medical KOD Class II 1981-01-02
K803105 SARNS INFANT ARTERIAL BUBBLE SENSOR 3M Health Care, Sarns KPL Class II 1980-12-31
K802983 THE INQUINAL RESORVOIR INSERTER Lone Star Medical Products, Inc. KOA Class I 1980-12-30
K803082 ADHESIVE PERISTOMAL COVERING W/WO CONN. Johnson & Johnson Professionals, Inc. EXB Class I 1980-12-22
K802956 GAMBRO A-V FISTULA NEEDLE SET Gambro, Inc. FIE Class II 1980-12-22
K802389 GAMBRO LUNDIA PLATE DISP. DIALYZER Gambro, Inc. FJG Class II 1980-12-22
K802230 BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP Cardio Med Supplies, Inc. FIF Class II 1980-12-22
K803048 VANCE UROSTOMY APPLIANCE Vance Products, Inc. EXB Class I 1980-12-22
K803079 FOLEY CATHETER American Hospital Supply Corp. KOD Class II 1980-12-22
K803080 ALL PUPOSE URETHRAL CATHETER American Hospital Supply Corp. KOD Class II 1980-12-22
K802729 URINE COLLECTION BAG TYPE 2132V Bio D Corp. KNX Class II 1980-12-18
K802735 URINE COLLECTION BAG TYPE 740AP Bio D Corp. KNX Class II 1980-12-18
K802733 URINE COLLECTION BAG TYPE AP2090V Bio D Corp. KNX Class II 1980-12-18
K802114 NEPHROSS DIALYZER Organon Teknika Corp. FJI Class II 1980-12-18
K802739 URINE COLLECTION BAG TYPE 710AP Bio D Corp. KNX Class II 1980-12-18
K801672 MEDCOMP SUBCLAVIAN CATHETER Medical Components, Inc. LFJ Class II 1980-12-18
K802831 GAMBRO PERITONEAL DIALYSIS MONITOR Gambro, Inc. KPF Class II 1980-12-18
K802732 URINE COLLECTION BAG TYPE AP2132V Bio D Corp. KNX Class II 1980-12-18
K802734 URINE COLLECTION BAG TYPE 710 Bio D Corp. KNX Class II 1980-12-18
K802736 URINE COOLECTION BAG TYPE 2090V Bio D Corp. KNX Class II 1980-12-18
K802122 CLIRANS TH13 HOLLOW FIBER DIALYZER Terumo America, Inc. FJI Class II 1980-12-18
K802441 CLIRANS TH10 HOLLOW FIBER DIALYZER Terumo America, Inc. FJI Class II 1980-12-18
K801633 THE BRAVO NEW PARALLEL FLOW DIALYZER Bellco Artifidial Organ Spec., Inc. FJG Class II 1980-12-18
K802737 URINE COLLECTION BAG TYPE 1590V Bio D Corp. KNX Class II 1980-12-18
K802738 URINE COLLECTION BAG TYPE 1505V Bio D Corp. KNX Class II 1980-12-18
K802092 HF-100 DIALYZER Bio-Med Corp. FJI Class II 1980-12-18
K802880 EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS Extracorporeal Medical Specialities, Inc. FKP Class II 1980-12-17
K802954 DRESSING CHANGE TRAY-MEDIUM Associated Medical Products Co. FKO Class II 1980-12-17
K801634 THE VITA 2 DISPOSABLE DIALYZER Bellco Artifidial Organ Spec., Inc. FHS Class II 1980-12-17
K802875 ARGYLE HEMATURIA BALLOON CATHETER Sherwood Medical Co. KOD Class II 1980-12-16
K802667 ARGYLE CLOSED URINARY DRAINAGE SET Sherwood Medical Co. KNX Class II 1980-12-16
K802474 CMR 300, ROWATER TREATMENT UNIT U-Marc, Inc. FIP Class II 1980-12-15
K802250 DIALYSIS CONTROL UNIT-CENTRY 2000 Cobe Laboratories, Inc. FKP Class II 1980-12-10
K802874 ARTERIOVENOUS BLOOD TUBING SETS Extracorporeal Medical Specialities, Inc. FJK Class II 1980-11-25
K802374 ROBERTSON OBTURATION MONITOR INSUFFLA Endotek Corp. FAP Class II 1980-11-24
K802465 BICARB-O-MATE HEMODIALYSIS SOD. BICARB. Renal Systems, Inc. FKR Class II 1980-11-12
K802677 CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON Johnson & Johnson Professionals, Inc. EXB Class I 1980-11-12
K802466 DISSCAP HOLLOW FIBER DIALYZER Hospal Medical Corp. FJI Class II 1980-11-12
K802664 URINARY DRAINAGE UNT Diamed Division Ill. Tool Works, Inc. KNX Class II 1980-11-12
K802665 TOUCHLESS CLEAN-CATH Diamed Division Ill. Tool Works, Inc. KOD Class II 1980-11-12
K802322 MODEL SD-1 DISINTEGRATOR Northgate Research, Inc. FFK Class II 1980-11-10
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
K802585 FEEDING TUBES IN SILICONE 5,6,8&10 SIZES The Healthcare Group Laboratories, Inc. KNT Class II 1980-10-31
K802433 BARD MALE EXTERNAL CATHETER C.R. Bard, Inc. KNX Class II 1980-10-31

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