meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
43
Latest Decision
1984-10-02

Clearances · page 99 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842679 ESOPHAGEAL DILATOR SET Mill-Rose Laboratory FAT Class II 1984-10-02
K842147 CATH-TECH CHOLANGIOGRAPHY CATHETER Catheter Technology Corp. FGE Class II 1984-10-02
K842206 DIAFLEX NEPHROSTOMY BALLOON DILATOR American Edwards Laboratories EZN Class II 1984-10-02
K842398 SUR-FIT IRRIGATION ADAPTER FACEPLATE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1984-10-01
K843135 BRIMFIELD CANNULATED MAGNETIC RETRIEVER Brimfield Scientific Instruments FCC Class II 1984-09-26
K842513 HEMOPERFUSION PROCEDURE W/REDY 2000 Organon Teknika Corp. FKT Class II 1984-09-12
K840937 CAPILLARY FLOW DIALYZERS Travenol Laboratories, S.A. KOC Class II 1984-09-12
K842131 FORMACLEAR- & MULTIPLE Rna Medical Corp. FKQ Class II 1984-09-10
K842119 OSTOMY OR UROSTOMY ABDOMINAL BELT OS Atlas Surgical Belt Co., Inc. EXB Class I 1984-09-10
K841986 PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG Protomed Corp. KNT Class II 1984-09-10
K842228 AIMED FOLEY CATHETER VARIOUS SIZES Tech-Cons Ltd., Intl. KOD Class II 1984-09-10
K842866 URETHRAL CATHETERIZATION TRAY Inmed Corp. KOD Class II 1984-09-10
K842890 PERCUFIX CATHETER CUFF Medi-Tech, Inc. KOD Class II 1984-09-04
K842997 LASER RECTOSCOPE SET 784 Laser Industries , Ltd. FDC Class II 1984-08-27
K842139 THE DENVER PLEURAL-PERITONEAL SHUNT Denver Biomedicals, Inc. KPM Class II 1984-08-27
K842302 FLUID WARMER Organon Teknika Corp. FLA Class II 1984-08-27
K841769 INTERMITTENT URETHRAL CATHETER TRAY Seamless Hospital Products Co. KOD Class II 1984-08-24
K840845 HOLLOW FIBER DIALYZERS Travenol Laboratories, S.A. KOC Class II 1984-08-16
K842589 IVAC KEOFEED HYDROPHILIC FEEDING TUBE Y KNT Class II 1984-08-14
K842841 VIVONEX TUNG STEN TIP TUBE Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1984-08-14
K842076 MIC GASTROSTOMY TUBE Medical Innovations Corp. KNT Class II 1984-08-14
K842609 R.L. MEDICAL TWIN LIGHT SOURCE Tridak Division of Indicon, Inc. FCW Class II 1984-08-09
K841941 VAN-TEC OCCLUSION BALLOON CATHETER Van-Tec, Inc. KOD Class II 1984-08-08
K842124 EMG MODULE, EMG1, W/OPTIONAL SPEAKER Endotek Corp. FAP Class II 1984-08-08
K842130 G.I. CLEANSING KIT Mmi, Inc. FCE Class I 1984-08-08
K842257 CORPAK URINARY DRAINAGE BAG Corpak Co. KNX Class II 1984-08-08
K842396 ACCUSEAL LEG BAGS & EXTENSION TUBES Convatec, A Division of E.R. Squibb & Sons KNX Class II 1984-08-08
K841929 LIFEMED LIFECOIL CATHETERS Lifemed of California FKX Class II 1984-08-08
K842864 VACCESS FEMORAL CANNULA Vas-Cath of Canada , Ltd. KNZ Class II 1984-08-08
K842397 URIHESIVE SYS MALE EXTERNAL CATHETER Convatec, A Division of E.R. Squibb & Sons KNX Class II 1984-08-08
K842395 SUR-FIT NIGHT DRAINAGE CONTAINER SET Convatec, A Division of E.R. Squibb & Sons KNX Class II 1984-08-08
K841940 VAN-TEC URETERAL DILATION BALLOON CATH Van-Tec, Inc. EZN Class II 1984-08-03
K842215 ASCORBIC ACID Organon Teknika Corp. FIP Class II 1984-08-02
K834455 MONOXYCHLOROSENE WAREXIN Guardian Chemical FKQ Class II 1984-07-31
K842154 PACKETS FOR THE PREP OF DIALYSATES & Organon Teknika Corp. FKQ Class II 1984-07-31
K832290 CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE Travenol Laboratories, S.A. KNX Class II 1984-07-31
K841310 GASTROINTESTINAL DILATOR Thomas J. Fogarty, M.D. KNQ Class II 1984-07-31
K841945 ENTERAL FEEDING BOTTLE Superior Plastic Products Corp. KNT Class II 1984-07-26
K842058 HEMODIALYSIS BATH CONCENTRATE SOLUTION Pharmaceutical Development Systems FKQ Class II 1984-07-26
K842416 DUO FLOW CATHETER-MC 54 Medical Components, Inc. KNZ Class II 1984-07-26
K841349 ESOPHAGEAL TUBE E. Benson Hood Laboratories, Inc. KNT Class II 1984-07-23
K842553 CHESEBROUGH-POND'S REUSABLE URINARY LEG Chesebrough-Pond'S U.S.A. Co. KNX Class II 1984-07-20
K841331 OLYMPUS KC-10 MOBILE DISINFEC-STAT Keymed, Inc. NZA Class II 1984-07-19
K841819 CORPAK FOLEY CATH TRAY W/16FR. TEFLON Corpak Co. KOD Class II 1984-07-19
K841678 STERILE, FOLEY CATHETERS W/PTFE COAT Abco Dealers, Inc. KOD Class II 1984-07-19
K841953 ULTRA SHIELD BRIEFS Ipco Corp. EYQ Class I 1984-07-19
K841384 PROXIMA 1 PH MONITOR American Endoscopy, Inc. FFT Class I 1984-07-19
K841942 SEGURA BASKET Van-Tec, Inc. FFL Class II 1984-07-19
K840208 CODE 17-ENDOSCOPE DEODORANT Knox Laboratories FEB Class II 1984-07-19
K840613 COLON IRRIGATION UNIT Colenz Co. KPL Class II 1984-07-17
K841153 ADAPTOR HR-3000 REUSE Colorado Medical, Inc. LIF Class II 1984-07-16
K842436 ERIKA NEGATIVE PRESS. ARTERIAL BLOOD Erika, Inc. KOC Class II 1984-07-13
K841511 HAEMATURIA CATHETERS Warne Surgical Products, Ltd. KOD Class II 1984-07-12
K841544 AMER. PHARMASEAL SILICONIZED LATEX American Pharmaseal Div. Ahsc KOD Class II 1984-07-09
K841791 PLUME FISTULA NEEDLE Hospal Medical Corp. FIQ Class II 1984-07-09
K841428 JEJUNOSTOMY SET FOR TUBE FEEDING Burron Medical Products, Inc. KNT Class II 1984-07-09
K841173 OSTOMY FREEDOM KIT Ellenberg Assoc. EXB Class I 1984-07-09
K841258 FOREIGN BODY PROTECTOR Jayco Pharmaceuticals FED Class II 1984-07-09
K841197 CYSTO-AID E-Z-Em, Inc. KNX Class II 1984-07-09
K841289 RECTAL IRRIGATION TUBE Hdc Corp. KNT Class II 1984-07-06
K841169 CURITY RIG FOLEY CATH TRAY The Kendal Co. KNX Class II 1984-07-06
K842258 RENATRON Renal Systems, Inc. LIF Class II 1984-07-06
K841152 HOSPAL BIOSPAL SCU/CAVH KIT Hospal Medical Corp. KDI Class II 1984-07-06
K841403 HEMO-RO WATER PURIFICATION SYS Millipore Corp. FIP Class II 1984-07-06
K840934 MEDILOG PH1 Oxford Medilog, Inc. EXW Class II 1984-06-28
K841716 ENDOPORT EROCAR Endotherapeutics FBQ Class II 1984-06-28
K842294 DIALYSATE ADDITIVES Dialysis Products, Inc. FKQ Class II 1984-06-28
K833128 FORMA-FAS-TEST Chemical Detection & Experimentation LIF Class II 1984-06-27
K832705 ULTRAMAX Medicorp, Inc. LIF Class II 1984-06-25
K841530 DOUBLE LUMEN SUBLCAVIAN-FEMORAL Medical Components, Inc. KNZ Class II 1984-06-25
K842305 C.A.P.D. AUTOMATIC HEATER PDH 200 Medionics International , Ltd. FKX Class II 1984-06-25
K831174 FILTRYZER HOLLOW FIBER ARTIFICIAL KID- Erika, Inc. KOC Class II 1984-06-22
K831173 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER Erika, Inc. KOC Class II 1984-06-22
K831175 FILTRYZER HOLLOW FIBER ARTIF. KIDNEY Erika, Inc. KOC Class II 1984-06-22
K831176 FILTRYZER HOLLOW FIBER ARTIF. KIDNEY Erika, Inc. KOC Class II 1984-06-22
K834547 ANGIOSCOPY CATHETER American Edwards Laboratories LYK Class II 1984-06-11
K840687 KIDNEY TRANSPLANT CATHETER Warne Surgical Products, Ltd. KDN Class II 1984-06-07
K840722 ENTEROSCOPE Trimedyne, Inc. FDA Class II 1984-06-07
K841727 UROLOGICAL CATHETER & ACCESSORIES Research Medical, Inc. KOD Class II 1984-06-07
K840864 GORE-TEX CATHETER W. L. Gore & Associates, Inc. KNT Class II 1984-06-01
K840532 HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. FLD Class II 1984-05-30
K834228 LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. FFK Class II 1984-05-25
K840859 MAKS CENTRAL DELIVERY SYS-11-200 ETC Erika, Inc. KOC Class II 1984-05-22
K834413 DILATION BALLOON CATHETER Hobbs Medical, Inc. FGE Class II 1984-05-22
K841543 CONCENTRATE CONDUCTIVITY METER Renal Systems, Inc. FKQ Class II 1984-05-22
K841330 GASTROSTOMY FEEDING TUBE Microvasive KNT Class II 1984-05-22
K840144 YAG LASER 8000 GASTROINTESTINAL BLEE Cooper Medical Corp. FCG Class II 1984-05-18
K841307 BBL GASPAK POUCH Bd Becton Dickinson Vacutainer Systems Preanalytic FKJ Class II 1984-05-14
K841387 WESTON RECTAL SNARE Imm Enterprises , Ltd. KOA Class I 1984-05-09
K841386 KOLLMANN URETHRAL DILATOR Imm Enterprises , Ltd. KOE Class II 1984-05-09
K841485 UROLOGICAL KIT W/STERILE, WATER-FILL Medline Industries, Inc. KOD Class II 1984-05-09
K841396 TRANSFER TROLLEY Setma, Inc. FDA Class II 1984-05-07
K840723 SWEEN-A-PEEL PERISTOMAL WAFERS Sween Corp. EXB Class I 1984-05-07
K840654 DIALYSIS ADMIN. SET - I.V. Cp Medical KOC Class II 1984-05-02
K841257 STA-POTENT SYSTEM Nu-Potent LKY Class II 1984-05-02
K841224 URO-MALE INCONTINENCE CATHETER Gil-Med Industries C/O Kegan & Kegan, Ltd. KNX Class II 1984-05-02
K840752 ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT E-Z-Em, Inc. KNT Class II 1984-05-02
K840182 RENAPAK CONCENTRATE MIXING SYS. Renal Systems, Inc. FKQ Class II 1984-05-02
K833567 COMFEEL PROTECTIVE FILM Coloplast A/S EXB Class I 1984-05-02
K840567 ACTIVE LIFE ONE-PIECE STOMA CAP Convatec, A Division of E.R. Squibb & Sons EXB Class I 1984-05-02

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