meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
59
Latest Decision
1991-02-21

Clearances · page 83 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910132 STRYKER LAPAROSCOPE Stryker Corp. GCJ Class II 1991-02-21
K905641 FST CATH-UD CATHETER Fiberoptic Sensor Technlogies, Inc. FEN Class II 1991-02-19
K910006 AVD INTIMAX (TM) BILIARY CATHETER Applied Vascular FGE Class II 1991-02-13
K905707 BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS Baxter Healthcare Corp FGE Class II 1991-02-13
K905164 TUBE DECLOGGER Nova Design Technologies, Ltd. KNT Class II 1991-02-13
K905793 COBE CENTRY 2 BICART OPTION KIT Cobe Laboratories, Inc. FKP Class II 1991-02-12
K904987 VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) Vibronics KNW Class II 1991-02-11
K905388 COBE CENTRYSYSTEM 3 BICART OPTION KIT Cobe Laboratories, Inc. FKP Class II 1991-02-11
K904992 MINNILERT AIR DETECTOR Minntech Corp. FJF Class II 1991-02-05
K905714 ERCP CANNULA Everest Medical Corp. FGE Class II 1991-02-01
K904434 SEXTON CYSTOTOMY URINE PUMP (SCUP2) Phoenix Bioengineering, Inc. KOB Class II 1991-02-01
K905195 FIRM MASTER Bak Medical Products LKY Class II 1991-02-01
K905080 MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health LFJ Class II 1991-01-31
K905731 FLEXIBLE ENDOSCOPIC ELECTRODE Applied Urology, Inc. FAS Class II 1991-01-31
K902623 FLEXIFLO STOMATE EXTENSION TUBE Abbott Laboratories KNT Class II 1991-01-31
K904983 MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY Meadox Surgimed, Inc. EZN Class II 1991-01-30
K904967 HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL Gambro-Hosp-Cobe, Inc. FKP Class II 1991-01-28
K904985 BIPOLAR BIOPSY FORCEPS Everest Medical Corp. KGE Class II 1991-01-25
K901320 ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG Ep Medical, Inc. KNX Class II 1991-01-25
K901125 PROVOCATIVE SENSITIVITY BALLOON Wilson-Cook Medical, Inc. KLA Class II 1991-01-25
K905124 MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE Red Wing Imaging, Inc. GCT Class II 1991-01-25
K905574 SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF E-Z-Em, Inc. FGD Class II 1991-01-24
K903529 BML SERIES Olympus Corp. LQC Class II 1991-01-23
K905376 STORZ S6000 LIGHT SOURCE Storz Instrument Co. FCW Class II 1991-01-23
K903715 CONDOM SEAL Mark Sullivan, M.D., P.C. EXJ Class I 1991-01-23
K903842 ST-E1 OVERTUBE Olympus Corp. FED Class II 1991-01-23
K904779 BUTTON REPLACEMENT GASTROSTOMY DEVICE C.R. Bard, Inc. KGC Class II 1991-01-18
K905042 COMFORT SLEEVED ALL SILICONE FOLEY CATHETER Rochester Medical Corp. EZL Class II 1991-01-18
K905229 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS Arrow Intl., Inc. FGE Class II 1991-01-18
K902910 CYTOASPIRATOR H & B Medical Technology, Inc. FCK Class II 1991-01-16
K904801 ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE Orion Life Systems, Inc. KGC Class II 1991-01-16
K904806 CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR Fresenius USA, Inc. KDJ Class II 1991-01-11
K904912 TRANSDUCER PROTECTOR Filtertek, Inc. FIB Class II 1991-01-04
K904231 MODEL OSP, SANDHILL AMS Sandhill Scientific, Inc. FAD Class II 1991-01-02
K904472 GLASSMAN STONE EXTRACTION SET Wilson-Cook Medical, Inc. LQR Class II 1990-12-28
K904557 MICROFLO Life-Tech Intl., Inc. EXY Class II 1990-12-28
K905015 SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE Surgitek LKY Class II 1990-12-28
K904586 PALEX IRRIGATION SET Palex Intl. SA EXD Class II 1990-12-28
K902993 SYSTEMS FLOW 2000 Universal Hydrotech, Inc. KPL Class II 1990-12-24
K896734 FEEDING TUBE Unoplast A/S FPD Class II 1990-12-21
K904534 ENEMA BULB R.A.C., Inc. FCE Class I 1990-12-21
K900924 WILSON-COOK BALLOON DILATION CATHETERS Wilson-Cook Medical, Inc. KNQ Class II 1990-12-21
K905016 PEDIATRIC AND INFANT CATH KITS Davol, Inc. FFH Class II 1990-12-20
K904376 ANEROID BLOOD PRESSURE GAUGE Biomedical Dynamics, Inc. FCY Class I 1990-12-20
K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES North American Sterilization & Packaging Co. FAS Class II 1990-12-18
K903162 FLEXIBLE ENDOSCOPIC ELECTRODES North American Sterilization & Packaging Co. FAS Class II 1990-12-18
K904485 SUPPORT RING Numedtec, Inc. LKY Class II 1990-12-14
K904486 SUPPORT PUMP Numedtec, Inc. LKY Class II 1990-12-14
K900509 NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH Medical Latex Corp. KOD Class II 1990-12-14
K904262 MINNOW PENILE IMPLANT PROTECTOR Ruja-Med Medical Marketing FAE Class II 1990-12-13
K903777 WRP FOLEYCATH Wembley Rubber Products (M) Sdn Bhd EZL Class II 1990-12-13
K903662 PEEWEE REPLACEMENT GASTROSTOMY TUBE Biosearch Medical Products, Inc. KNT Class II 1990-12-12
K904566 NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER Cobe Laboratories, Inc. FJI Class II 1990-12-12
K905228 MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ Baxter Healthcare Corp FJI Class II 1990-12-10
K903790 ENDOSCOPIC LIGHT SOURCE 250 ENDO Orlux Engineering and Instrumentation FCW Class II 1990-12-07
K900464 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Medical Innovations Corp. KNT Class II 1990-12-05
K904139 SINGLE LUMEN CATHETER KITS Akcess Medical Products, Inc. LFJ Class II 1990-12-04
K905128 FLEXI-TRAK(TM) ANCHORING DEVICE Convatec, A Division of E.R. Squibb & Sons KNY Class II 1990-11-29
K904158 ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY Welcon, Inc. FCM Class II 1990-11-29
K904386 UROLAB JANUS Life-Tech Intl., Inc. FAP Class II 1990-11-27
K903579 FLEXIFLO STOMATE DECOMPRESSION TUBE Abbott Laboratories KNT Class II 1990-11-27
K904210 RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 Minntech Corp. LIF Class II 1990-11-27
K904140 SINGLE LUMEN CATHETERS, MODIFICATION Akcess Medical Products, Inc. LFJ Class II 1990-11-27
K904299 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF E-Z-Em, Inc. FGD Class II 1990-11-27
K904433 DUAL LUMEN NEEDLES Akcess Medical Products, Inc. LBW Class II 1990-11-23
K902710 FOLEY CATHETER Societa Gruppi Elastomeri S.A. EZL Class II 1990-11-21
K900295 PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES Microwave Medical Systems, Inc. KDJ Class II 1990-11-21
K904734 PHARMASEAL DISPOSABLE ABDOMINAL TROCAR Baxter Healthcare Corp KOD Class II 1990-11-21
K902526 CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481 Baxter Healthcare Corp KDJ Class II 1990-11-20
K903945 EXEL A-V FISTULA SET Exel Intl. FIE Class II 1990-11-20
K903869 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET Fresenius/Delmed, Inc. KDJ Class II 1990-11-20
K903086 TUBE GASTROSTOMY Knight Medical, Inc. KGC Class II 1990-11-20
K902421 STOMACH, GASTRO-ENTEROSTOMY Gainor Medical Europe, Ltd. KDH Class II 1990-11-20
K902426 HEMODIALYSIS SYSTEM AND ACCESSORY Gainor Medical Europe, Ltd. FJK Class II 1990-11-20
K904658 AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV Leigh Med Tech, Inc. KNW Class II 1990-11-20
K901163 WILSON-COOK PULL THROUGH PEG KIT Wilson-Cook Medical, Inc. FPD Class II 1990-11-19
K903036 P.R.G. GUIDEWIRE PLACEMENT SYSTEM Applied Medical Technologies KGC Class II 1990-11-19
K903325 FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT Abbott Laboratories KNT Class II 1990-11-19
K903337 1.9 FRENCH LITHOTRIPTER ELECTRODE Northgate Research, Inc. FFK Class II 1990-11-16
K903641 QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q Bentley Laboratories, Inc. KDI Class II 1990-11-09
K902099 WILSON-COOK VARICES TAMPONADE BALLOON CUFF Wilson-Cook Medical, Inc. KNT Class II 1990-11-07
K903813 URETERAL BALLOON DILATATION CATHETER Boston Scientific Corp EZN Class II 1990-11-07
K896729 NELATON-, FEMALE - OR TIEMANN CATHETER Unoplast A/S KOD Class II 1990-11-05
K903646 GASTROGRAPH Medics Instrument Corp. FFT Class I 1990-11-05
K896732 UNOMETER 500 Unoplast A/S EXR Class II 1990-11-02
K900371 MENTOR MODIFIED MALLEABLE PENILE PROSTHESES Mentor Corp. FAE Class II 1990-11-02
K902837 AMICON DIAFILTER 30 HEMOCONCENTRATOR Amicon, Inc. KDI Class II 1990-11-01
K903816 URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR Respiratory Support Products, Inc. EZK Class II 1990-10-31
K902149 FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM Fresenius/Delmed, Inc. FKX Class II 1990-10-30
K903611 ILC LEG BAG HOLDER Inman Liebelt Corp. FAQ Class I 1990-10-26
K901922 SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 Safte S.P.A. EXN Class I 1990-10-26
K900923 ZIMMON ENDOSCOPIC PANCREATIC STENT Wilson-Cook Medical, Inc. FGE Class II 1990-10-26
K901494 ETUDE, URODYNAMIC INVESTIGATION SYSTEM Dantec Medical, Inc. FAP Class II 1990-10-26
K903459 PRECISION OPTICS ENDOSCOPE ADAPTER Precise Optics FET Class II 1990-10-26
K903342 DEODORIZING AND SOUND MUFFLING ANAL PAD Biological Resistance, Inc. EYQ Class I 1990-10-23
K903502 LIFECOIL CATHETER Lifemed of California FJS Class II 1990-10-22
K903420 SOEHENDRA STENT RETRIEVER Wilson-Cook Medical, Inc. FGE Class II 1990-10-22
K903457 PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) Precise Optics FET Class II 1990-10-19
K903458 PRECISION OPTICS IMAGE COUPLER Precise Optics FET Class II 1990-10-19
K885037 AMUKIN 50% - AIRSPRAY(R) Bernard J. Cooney, P.A. FKO Class II 1990-10-19

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