meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1985-06-18

Clearances · page 97 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852105 MANAN UBK ULTRASONIC GUIDED BIOPSY KIT Manan Manufacturing Co., Inc. FCH Class I 1985-06-18
K851671 GASTROINTESTINAL TUBE Sheridan Catheter Corp. KNT Class II 1985-06-14
K852070 SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL Shiley, Inc. LFJ Class II 1985-06-13
K850778 SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE Settler Medical Electronics, Inc. FFT Class I 1985-06-13
K851956 VPDS-1 VENNES PANCREATIC DILATION SET Wilson-Cook Medical, Inc. FGE Class II 1985-06-13
K851964 E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE Wilson-Cook Medical, Inc. KNS Class II 1985-06-13
K852134 BSM 22 BLOOD SAFETY MODULE Hospal Medical Corp. KOC Class II 1985-06-12
K852162 MNI 400 INJECTION CAPS Med-West, Inc. LFJ Class II 1985-06-12
K851876 PREFER INCONTINENCE AID Rocky Mountain Medical Corp. EYQ Class I 1985-06-12
K851431 HEMODIALYSIS CONCENTRATE ADDITIVES Dana Laboratories KPO Class II 1985-06-12
K851306 COBE SYSTEM 3 Cobe Laboratories, Inc. FKP Class II 1985-06-12
K851471 TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR Lic-Orthion KNX Class II 1985-06-12
K852297 JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT Johnson & Johnson Professionals, Inc. EXB Class I 1985-06-12
K851362 STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF Rna Medical Corp. FKH Class II 1985-06-12
K851470 BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR Lic-Orthion KNX Class II 1985-06-12
K851539 CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO Chesebrough-Pond'S U.S.A. Co. KNT Class II 1985-06-12
K852135 BSM 21 BLOOD SAFETY MODULE Hospal Medical Corp. KOC Class II 1985-06-12
K850435 SARTORIUS AQUASART SM 40035 - DIALYSATE SYS Sartorius Filters, Inc. FKR Class II 1985-06-04
K850751 DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY Biolog, Inc. EXB Class I 1985-05-23
K850750 DISPOSABLE UROSTOMY POUCH Biolog, Inc. EXB Class I 1985-05-23
K851398 BARD PERISTOMAL PASTE C.R. Bard, Inc. EXB Class I 1985-05-23
K851797 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH Artiberia FFQ Class I 1985-05-23
K844790 RENAFLO HEMOCONCENTRATOR Renal Systems, Inc. KDI Class II 1985-05-23
K851734 OMNIMED SUPERIOR TRANSDUCER PROTECTOR Omni Intl., Inc. FIB Class II 1985-05-23
K851798 53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN Artiberia KNW Class II 1985-05-23
K851463 OLBERT CATHETER SYS FOR URETERAL DILATION Meadox Surgimed, Inc. EZN Class II 1985-05-23
K851096 HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM Olympus Corp. KNS Class II 1985-05-22
K851428 TRANDUCER PROTECTOR Galvin Industries, Inc. FIB Class II 1985-05-21
K850696 WSP CODE 4300 DIOMASTER DIAGNOSTIC Warne Surgical Products, Ltd. FAP Class II 1985-05-17
K850694 WSP CODE 4310 STRESSCATH Warne Surgical Products, Ltd. FAP Class II 1985-05-17
K851835 MANAN GREENE NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-05-17
K844734 ALCIDE REN NEW-D Alcide Corp. FKQ Class II 1985-05-17
K850695 WSP CODE 4301 DIOMASTER THERAPEUTIC Warne Surgical Products, Ltd. FAP Class II 1985-05-16
K851837 MANAN WESTCOTT NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-05-14
K851831 MANAN FRANSEENE NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-05-14
K850693 WSP CODE 4315 PADTEST Warne Surgical Products, Ltd. FAP Class II 1985-05-10
K851444 KEITH-A.R.V. Karl M. Block Co. KNT Class II 1985-05-10
K850361 SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E Synectics-Dantec FFT Class I 1985-05-01
K851453 HOSPAL FISTULA NEEDLE Hospal Medical Corp. FIE Class II 1985-04-29
K850602 1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE Life-Tech Intl., Inc. FAP Class II 1985-04-25
K851380 DISSCAP 110 DIALYZER Hospal Medical Corp. FJI Class II 1985-04-25
K851180 IRRIGATION TRAY Pace Pharmaceutical Services, Inc. KOD Class II 1985-04-25
K850601 MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR Life-Tech Intl., Inc. FAP Class II 1985-04-25
K851179 CATHETER CARE TRAY Pace Pharmaceutical Services, Inc. KOD Class II 1985-04-25
K844774 EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS Mecron Medical Products, Inc. FCR Class II 1985-04-22
K850169 ERIS URO-DIAGNOSTIC SYSTEM Eris Medical Technology FFG Class II 1985-04-22
K851364 FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP Precision Dynamics Corp. KNW Class II 1985-04-22
K850489 ENDOSOPIC STENE MANIPULATING BALLOON Mill-Rose Laboratory LQR Class II 1985-04-22
K843792 VAN JON SUPER CLYSTER(KIT, ENEMA Van Jon Co. FCE Class I 1985-04-22
K850268 SPARCO SCOPE GUARD Sparco, Inc. FEB Class II 1985-04-15
K851162 AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER Van-Tec, Inc. KOA Class I 1985-04-15
K851158 VAN-TEC MEATAL DILATOR Van-Tec, Inc. KOE Class II 1985-04-15
K851188 PACKETS FOR PREP. OF DIALYSATES & INFUSATES - Organon Teknika Corp. FKT Class II 1985-04-12
K850167 }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR Urologics, Inc. KPI Class II 1985-04-09
K850019 OMNI PHASE PENILE PROSTHESIS Dacomed Corp. FAE Class II 1985-04-09
K851144 URETERAL DILATION SET Van-Tec, Inc. EZN Class II 1985-04-09
K851230 GAMBRO PRESSURE MONITOR GUARDS Gambro, Inc. FIB Class II 1985-04-09
K851207 EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 Travenol Laboratories, S.A. KDJ Class II 1985-04-08
K851208 COMPACT EXCHANGE DEVICE 5C4197 Travenol Laboratories, S.A. KDJ Class II 1985-04-08
K850954 URETERAL DILATOR & URETERAL STONE DISLODGER American Edwards Laboratories FFL Class II 1985-04-03
K844866 NYTONE ENURETIC ALARM BEDWETTING DEVICE Nytone Medical KPN Class II 1985-04-03
K851112 RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER The Huxley Instrument Corp. KOA Class I 1985-04-03
K850538 BED SENTRY, MODEL 50U Metatech Corp. KPN Class II 1985-04-03
K851111 RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV The Huxley Instrument Corp. KOA Class I 1985-04-03
K850865 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- Erika, Inc. FJI Class II 1985-04-03
K851113 RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR The Huxley Instrument Corp. KOA Class I 1985-04-03
K850866 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L Erika, Inc. KDI Class II 1985-04-03
K844636 SENTRY SIGNAL ENURESIS ALARM SYSTEM Conklin Technology, Inc. KPN Class II 1985-04-03
K844850 MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT Medicorp, Inc. FKQ Class II 1985-04-02
K832170 MUFFLER GAS-AIR VENT UNIT Dr. Edward Richards KNT Class II 1985-04-02
K850790 DIAFLEX OCCLUSION BALLOON CATHETER American Edwards Laboratories KOD Class II 1985-03-25
K840837 TBI TRAINER Manico FEJ Class I 1985-03-25
K850127 FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G Computer Dialysis Systems, Inc. LIF Class II 1985-03-20
K850756 AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS Travenol Laboratories, S.A. FKR Class II 1985-03-20
K845042 ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories FKX Class II 1985-03-19
K850182 IVAC KEOFEED II POLYURETHANE FEEDING TUBE Y KNT Class II 1985-03-19
K844434 VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH Vas-Cath of Canada , Ltd. LFJ Class II 1985-03-13
K844336 VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH Vas-Cath of Canada , Ltd. LFJ Class II 1985-03-13
K844433 VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA Vas-Cath of Canada , Ltd. LFJ Class II 1985-03-13
K850569 BSM 2000 DIALYSIS MACHINE - MODIFIED Organon Teknika Corp. FKP Class II 1985-03-12
K850335 URETEROSCOPY CATHETER Inmed Corp. KOD Class II 1985-03-12
K844630 ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM Organon Teknika Corp. FKX Class II 1985-03-12
K850355 MENTOR PERCUTANEOUS RENAL DILATOR SET Mentor Corp. EZN Class II 1985-03-12
K850175 MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S Mentor Corp. FAD Class II 1985-03-07
K850654 TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID Erika, Inc. FJI Class II 1985-03-07
K850655 TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 Erika, Inc. FJI Class II 1985-03-07
K850298 ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM Cabot Medical Corp. FEO Class II 1985-03-05
K850176 MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL- Mentor Corp. FAD Class II 1985-02-28
K850179 MBM(TM) MONITRAL (R) BICARBONATE MODULE Hospal Medical Corp. FKP Class II 1985-02-28
K850285 GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY Premium Plastics, Inc. KOD Class II 1985-02-28
K844993 COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 Omnis Surgical, Inc. FCG Class II 1985-02-28
K850438 RENAL BIOPSY TRAY Packaging Technologies, Inc. KNW Class II 1985-02-26
K850611 ATTENDS INCONTINENT UNDERGARMENT Procter & Gamble Mfg. Co. EYQ Class I 1985-02-26
K844338 1URO-LOG HOME DIAGNOSTIC PACK Epcom Medical Systems, Inc. FFG Class II 1985-02-25
K845041 CAPD STAGED CONNECTOR Abbott Laboratories FKO Class II 1985-02-21
K850406 AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. FKX Class II 1985-02-21
K844750 FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD Seratronics, Inc. FKQ Class II 1985-02-15
K843567 KANGAROO NASOGASTRIC FEEDING TUBE Chesebrough-Pond'S U.S.A. Co. KNT Class II 1985-02-14
K850153 ADULT DISPOS. INCONTINENT PANTS Convatec, A Division of E.R. Squibb & Sons EYQ Class I 1985-02-14
K850074 ESOPHOGEAL PH CATHETER Biosearch Medical Products, Inc. FFT Class I 1985-02-14

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