meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
38
Latest Decision
1980-05-08

Clearances · page 109 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K800971 M.R. ASSOC. MAGNETIC EXTRACTOR Mr Associates, Inc. FCC Class II 1980-05-08
K800666 QUIK-TEMP Liquid Crystal Products, Inc. KPP Class II 1980-05-08
K800750 STOMAHESIVE STERILE WAFER Squibb & Sons, Inc. EXB Class I 1980-05-08
K800970 M.R. ASSOC. BASKET RETRIEVERS Mr Associates, Inc. OCZ Class II 1980-05-08
K800968 M.R. ASSOC. RAT TOOTH GRASP FORCEPS Mr Associates, Inc. OCZ Class II 1980-05-08
K800972 M.R. ASSOC. TRIPOD GRASPING FORCEPS Mr Associates, Inc. OCZ Class II 1980-05-08
K800965 M.R. ASSOC. SNARES; CRESCENT SNARE WIRE Mr Associates, Inc. KNS Class II 1980-05-08
K800973 M.R. ASSOC. HOT BIOPSY FORCEPS Mr Associates, Inc. KNS Class II 1980-05-08
K800967 M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS Mr Associates, Inc. OCZ Class II 1980-05-08
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
K800975 M.R. ASSOC. TRUE-FEEL HANDLE Mr Associates, Inc. KNS Class II 1980-05-08
K800962 M.R. ASSOC. WASHING TUBE/MEASURING TUBE Mr Associates, Inc. ODC Class II 1980-05-08
K800336 GAMBRO LUNDIA FIBER Gambro, Inc. FJI Class II 1980-05-02
K800549 MODEL TRIEX-L HOLLOW FIBER DIALYZER Extracorporeal Medical Specialities, Inc. FJI Class II 1980-04-10
K800424 LUNDIA PLATE DISP. Gambro, Inc. FJG Class II 1980-04-10
K800609 CATHETER STYLET G.D. Searle and Co. KOD Class II 1980-04-10
K800305 WATER CONDUCTIVITY MONITOR & CONTROLLER Darco Water Systems, Inc. FIP Class II 1980-04-08
K792513 HEMODIALYSIS CONCENTRATE SOLUTION Mid Atlantic Nephrology Center KPO Class II 1980-04-08
K800510 RECTAL & HARRIS FLUSH TUBES Medi-Craft , Ltd. KNT Class II 1980-04-08
K800607 SUPRAPUBIC TROCAR G.D. Searle and Co. KOB Class II 1980-04-08
K800610 URETHRAL SOUND G.D. Searle and Co. KOE Class II 1980-04-08
K800505 URETHRAL CATHETER Medi-Craft , Ltd. KOD Class II 1980-04-08
K800611 BOUGIE A BOULE G.D. Searle and Co. KOE Class II 1980-04-08
K800441 RUDD-CLINIC HEMORRHOIDAL FORCEPS J. Sklar Mfg. Co., Inc. KOA Class I 1980-04-08
K800507 FEEDING TUBES Medi-Craft , Ltd. KNT Class II 1980-04-08
K800495 SUR-FIT UROSTOMY POUCH & URINARY BAG E. R. Squibb & Sons, Inc. EXB Class I 1980-04-08
K800608 STONE DISLODGER G.D. Searle and Co. FFL Class II 1980-04-08
K800330 MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic FKP Class II 1980-04-08
K800508 STOMACH TUBES Medi-Craft , Ltd. KNT Class II 1980-04-08
K800425 GAMBRO AK-10-UDM-10-A ULTRADIFFUSION Gambro, Inc. FKP Class II 1980-04-08
K800420 ADT PERCUTANEOUS NON-DISP. NEEDLE A.D.T. Lab Industries FCG Class II 1980-03-25
K800419 ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL A.D.T. Lab Industries FCG Class II 1980-03-25
K800416 ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA) A.D.T. Lab Industries FCG Class II 1980-03-25
K792252 DMS 3000 Renal Care Corp. FKQ Class II 1980-03-12
K800397 ELLIK BLADDER EVACUATOR Sage Products, Inc. KQT Class II 1980-03-10
K800307 IRRIGATION (3-WAY) FOLEY CATHETER Abco Dealers, Inc. KOD Class II 1980-02-28
K800306 FOLEY CATHETER Abco Dealers, Inc. KOD Class II 1980-02-28
K800321 CONCEPT SUCTION COAGULATOR Concept, Inc. KNS Class II 1980-02-28
K800308 PEDIATRIC FOLEY CATHETER Abco Dealers, Inc. KOD Class II 1980-02-28
K800221 CF/211 CAPILLARY FLOW DIALYZER, #5M1784 Travenol Laboratories, S.A. FJI Class II 1980-02-26
K800109 SURGITEK URINARY DIVERSION STENT Medical Engineering Corp. FAD Class II 1980-02-26
K800270 TRIEX-2 HOLLOW FIBER DIALYZER Extracorporeal Medical Specialities, Inc. FJI Class II 1980-02-26
K800186 LOGO-NU-WAY Gary Giancarlo KNX Class II 1980-02-26
K800174 GAMBRO LUNDIA COIL DIALYZER Gambro, Inc. FHS Class II 1980-02-13
K792611 GAMBRO LUNDIA PLATE DIALYZER Gambro, Inc. FJG Class II 1980-02-06
K792597 RECTAL LEAKAGE INHIBITOR Augustin Jones, M.D. KNT Class II 1980-02-06
K792651 CAPD TRANSFER SET JC9044 Travenol Laboratories, S.A. KDJ Class II 1980-02-06
K791512 CONTINUOUS AMBULATORY DIALYSIS (CAPD) Norton Performance Plastics Corp. KDJ Class II 1980-02-06
K792719 3 WAY URETHRAL IRRIGATION CATHETER Vesta, Inc. KOD Class II 1980-01-16
K792277 MODEL 7620 LINE CLAMP B-D Drake Willock KOC Class II 1980-01-16
K792333 BAKER INTESTINAL TUBE, TWIN CUFF Intl. Hospital Products, Inc. KNT Class II 1980-01-16
K792419 C-DAK 2100 ARTIFICIAL KIDNEY Cordis Corp. FJI Class II 1980-01-16
K792137 SORB SYSTEM URS Organon Teknika Corp. FKT Class II 1980-01-16
K791714 SURGIFEED Health Development Corp. KNT Class II 1980-01-16
K792213 RENAL SYSTEMS HEMODIALYSIS CONCENTRATE Renal Systems, Inc. KPO Class II 1980-01-04
K792382 STOMAHESIVE POWDER E. R. Squibb & Sons, Inc. EXB Class I 1979-12-20
K792512 POLAROID LAND CAMERA FOR ENDOSCOPY Polaroid Corp. FEM Class I 1979-12-20
K792345 RETRIEVABLE FORCEPS Mill-Rose Laboratory OCZ Class II 1979-12-20
K792344 STONE AND RETRIEVAL BASKET Mill-Rose Laboratory FFL Class II 1979-12-20
K792215 PENTEX UPPER G.I. SCOPE MODEL FG-28A Pentax Precision Instrument Corp. GCT Class II 1979-12-10
K792207 PERIDIAL PERITONEAL DIALYSIS TRAY Cutter Laboratories, Inc. FKG Class I 1979-12-10
K792381 BONGORT ODOR BARRIER DRAIN Howmedica Corp. EXB Class I 1979-12-10
K792341 PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 Pentax Precision Instrument Corp. FAM Class II 1979-12-10
K792090 BROWNE MODEL UD-4 Browne Corp. FAP Class II 1979-12-06
K792091 BROWNE MODEL UD-4D Browne Corp. FAP Class II 1979-12-06
K792314 RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN Icl Scientific FAM Class II 1979-12-06
K792220 VANCE KIDNEY BIOPSY BRUSHES Vance Products, Inc. KOD Class II 1979-12-06
K792054 ERIKA NEGATIVE PRESSURE VENOUS BL SETS Erika, Inc. FJK Class II 1979-12-06
K792221 VANCE PHILIPS FOLLOWER CATHETER & BOUGIE Vance Products, Inc. KOE Class II 1979-12-06
K792094 BROWNE MODEL UA-6 Browne Corp. FAP Class II 1979-12-06
K792092 BROWNE MODEL UD-4E Browne Corp. FAP Class II 1979-12-06
K791676 PERITONEAL DIALYSIS CYCLER MODEL PDC1000 J.M. Sounds Electronics Co. KPF Class II 1979-12-06
K792179 AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE American Optical Corp. FDF Class II 1979-12-06
K792093 BROWNE MODEL GD-5 Browne Corp. FAP Class II 1979-12-06
K792053 ERIKA NEGATIVE PRESSURE ARTERILA BLOOD Erika, Inc. FJK Class II 1979-12-06
K792219 VANCE MALLEABLE TIP FILIFORM Vance Products, Inc. KOE Class II 1979-12-06
K791598 CLOSED SYSTEM FOLEY CATHERIZATION PROCED Walpak Co. KOD Class II 1979-11-16
K792174 MODEL DM 353 & DM-353-L SINGLE NEEDLE Extracorporeal Medical Specialities, Inc. FIF Class II 1979-11-16
K792173 MODELS DM-360 & DM-350-L SINGLE PATIENT Extracorporeal Medical Specialities, Inc. FKP Class II 1979-11-16
K791584 CYLER/HEATER FOR PERITONEAL DIALYSIS American Medical Products, Inc. KPF Class II 1979-11-16
K791342 ADR-10600(ADR 400),10601 (ADR 300) Physio-Control Corp. FKX Class II 1979-11-16
K791722 DISPOSABLE PERITONEAL DIALYSIS EXTENSION American Medical Products, Inc. KDJ Class II 1979-11-16
K792107 CONPHAR 100% SILICONE FOLEY CATH-STER. Conphar, Inc. KOD Class II 1979-11-16
K792109 CONPHAR LATEX FOLEY CATH-STERILE Conphar, Inc. KOD Class II 1979-11-16
K792111 CONPHAR SILICONE COATED FOLEY CATH Conphar, Inc. KOD Class II 1979-11-16
K791899 CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 Travenol Laboratories, S.A. KDJ Class II 1979-11-13
K791411 COAXIAL DUAL FLOW CATHETER Terumo America, Inc. KOC Class II 1979-11-13
K791961 EXTRACORPOREAL'S MODEL EX-85 DIALYZER Extracorporeal Medical Specialities, Inc. FJG Class II 1979-11-13
K792037 NON-A-THERM Labarge, Inc. KOD Class II 1979-11-13
K792082 GAVAGE FEEDING SET Medical Devices, Inc. EYN Class II 1979-11-13
K792139 FEATHER-LITE URINARY DIV. POUCH Howmedica Corp. EXB Class I 1979-11-13
K792038 NELATON CATHETER American Hospital Supply Corp. KOD Class II 1979-11-13
K791674 BLADDER RETENTION CATHETERIZATION TRAY Latex Ind., Inc. KOD Class II 1979-11-05
K791969 DYNACOR STERILE CLOSED SYS. DRAINAGE BAG Medline Industries, Inc. KNX Class II 1979-11-05
K791758 CLINIFEEDING SYSTEM 1 Roussel (Canada) , Ltd. KNT Class II 1979-10-26
K791526 HOLLISTER STOMA POUCH SKIN BARRIER Hollister, Inc. EXB Class I 1979-10-26
K791525 HOLLISTER KARAYA PASTE Hollister, Inc. EXB Class I 1979-10-26
K791489 VITAL CATHETER Hospal Medical Corp. FIE Class II 1979-10-26
K791535 HOLLISTER STOMA POUCH WITH MICRO ADHES Hollister, Inc. EXB Class I 1979-10-26

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