meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
1997-11-14

Clearances · page 58 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971359 RESTORE (A.K.A. CAPSURE) Nebl, Inc. MNG Class I 1997-11-14
K973290 SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK Vaughan Weeks MPA Class II 1997-11-14
K973139 ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR Ethicon Endo-Surgery, Inc. GCJ Class II 1997-11-13
K970661 CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) Baxter Healthcare Corp MSE Class II 1997-11-12
K970654 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) Baxter Healthcare Corp MSE Class II 1997-11-12
K973113 MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM Boston Scientific Corp FGE Class II 1997-11-10
K973068 KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING Karl Storz Endoskop GmbH GCJ Class II 1997-11-07
K962554 FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE Abbott Laboratories KNT Class II 1997-11-07
K973757 D.O.R.C. SOLUX LIGHT SOURCE Dutch Ophthalmic USA, Inc. MPA Class II 1997-11-07
K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health EZD Class II 1997-11-07
K971757 LOW PROFILE FEEDING SET ACCESSORY Applied Medical Technologies KNT Class II 1997-11-07
K973070 CONVEEN EASICATH SET Coloplast Corp. EZD Class II 1997-11-06
K972927 ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR Richard Wolf Medical Instruments Corp. GCJ Class II 1997-11-06
K973215 STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM Laurus Medical Corp. KNW Class II 1997-11-06
K971295 AVE BRIDGE STENT SYSTEM Arterial Vascular Engineering, Inc. FGE Class II 1997-11-05
K972537 ERCO-VAC Ercons, Inc. LKY Class II 1997-11-03
K973565 QUICK-CARE BIOPSY NEEDLE Cook, Inc. KNW Class II 1997-11-03
K970482 TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 Srs Intl. KPL Class II 1997-10-31
K973253 ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE International Medical Products, Inc. KPO Class II 1997-10-30
K964661 HX-20/21-1 ENDOSCOPIC LIGATOR Olympus America, Inc. MND Class II 1997-10-30
K972984 LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE Lerner Medical, Inc. GCJ Class II 1997-10-29
K972353 ERCO-RIBBON Ercons, Inc. LKY Class II 1997-10-28
K971313 NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET National Medical Care, Inc. FJK Class II 1997-10-27
K971259 COMBIPORT FLUID LAVAGE DEVICE B.Braun Medical, Inc. KDH Class II 1997-10-27
K970595 CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP Circon Video FEN Class II 1997-10-24
K972471 DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES Smith & Nephew, Inc. GCJ Class II 1997-10-24
K973071 TRI TALON RETRIEVAL FORCEPS Medical Engineering Laboratory, Inc. OCZ Class II 1997-10-24
K971015 AHCS HEMOPERFUSION SYSTEM American Health Care Systems, Inc. FLD Class II 1997-10-22
K971897 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) Medron, Inc. LFK Class II 1997-10-21
K963858 FEMASSIST URINARY DEVICE Insight Medical Corp. MNG Class I 1997-10-21
K971576 REJOYN PENILE SUPPORT SYSTEM American Medtech LKY Class II 1997-10-16
K971137 BARD RAPIDFIRE MULTIPLE BAND LIGATOR C.R. Bard, Inc. MND Class II 1997-10-16
K973500 BARD ENDOSCOPIC OVERTUBE (#000307) C.R. Bard, Inc. FED Class II 1997-10-16
K972964 ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE Atrion Medical Products, Inc. KOE Class II 1997-10-10
K972977 INSULATOR WIRE GUIDE Cook Urological, Inc. KNY Class II 1997-10-10
K962977 MRI COMPATIBLE BIOPSY NEEDLES Manan Medical Products, Inc. KNW Class II 1997-10-09
K971320 CRE BALLOON DILATATION CATHETER Boston Scientific Corp KNQ Class II 1997-10-09
K972926 MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE KARL STORZ Endoscopy-America, Inc. FBN Class II 1997-10-08
K972825 OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB Cordis Corp. FGE Class II 1997-10-07
K971643 RUSCH BRILLANT BALLOON CATHETER Rusch Intl. EZL Class II 1997-10-07
K971257 VTU-1 VACUUM ERECTION SYSTEM Mckenna & Cuneo LKY Class II 1997-10-03
K972579 HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE Baxter Healthcare Corp KDJ Class II 1997-10-01
K972685 ORIGIN LIGATOR DEVICE Origin Medsystems, Inc. GCJ Class II 1997-10-01
K972578 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1997-10-01
K970650 ASAHI AM-R SERIES DIALYZERS Asahi Medical Co., Ltd. MSE Class II 1997-09-30
K973256 JIMMY JOHN III RECTAL NOZZLE Colon Therapeutics KPL Class II 1997-09-29
K972731 NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET Klein-Baker Medical, Inc. KDJ Class II 1997-09-29
K971768 RELIANT CHARGER Walling Medical Equipment Co. LKY Class II 1997-09-29
K970253 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare KDI Class II 1997-09-26
K971443 RAPPORT V.T.D. Owen Mumford USA, Inc. LKY Class II 1997-09-26
K970937 MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) Mist, Inc. GCJ Class II 1997-09-26
K955497 GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET Cobe Renal Care, Inc. KDL Class II 1997-09-25
K972439 ANORECTAL MANOMETRY ANALYSIS MODULE Medtronic-Synectics FFX Class II 1997-09-23
K971150 MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE Mist, Inc. GCJ Class II 1997-09-23
K972781 OT-1 Prism Therapeutics, LLC FED Class II 1997-09-19
K972958 LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS Lysonix, Inc. GCJ Class II 1997-09-19
K972679 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) Ethicon Endo-Surgery, Inc. GCJ Class II 1997-09-19
K971913 GR100F URINE FLOWMETER Albyn Medical , Ltd. EXY Class II 1997-09-19
K973114 SILICONE BILIARY STENT/BILIARY CATHETER Specialty Surgical Products, Inc. FGE Class II 1997-09-19
K972505 RESUABLE HOT BIOPSY FORCEPS United States Endoscopy Group, Inc. KGE Class II 1997-09-18
K972540 S-357 VIDEO IMAGING SYSTEM Sopro FET Class II 1997-09-18
K971315 AUXILIARY INSTRUMENTS FOR URS Richard Wolf Medical Instruments Corp. FCL Class I 1997-09-15
K973259 K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) Medical Creative Technologies, Inc. OCZ Class II 1997-09-10
K972455 JIMMY JOHN III RECTAL NOZZEL, MODEL CIT Colon Therapeutics KPL Class II 1997-09-09
K970591 BLOOD MONITOR PUMP Baxter Healthcare Corp KDI Class II 1997-09-09
K963354 5 STAR MEDICAL ENDOSCOPE Five Star Medical, Inc. ODF Class II 1997-09-08
K972178 UNISURGE INTERFACE P Unisurge Holding, Inc. GCJ Class II 1997-09-05
K970159 FLEX-NECK PD CATHETER Janin Group, Inc. FJS Class II 1997-09-05
K972091 AMS FOREIGN BODY EXTRATOR American Medical Systems, Inc. FFL Class II 1997-08-29
K972583 URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S Uresil Corp. FGE Class II 1997-08-29
K971499 FEMALE EXTERNAL URINARY COLLECTION POUCH Mediquest, Inc. EXI Class I 1997-08-28
K971475 SHIELDED SURGICAL TROCAR Ethicon Endo-Surgery, Inc. GCJ Class II 1997-08-21
K971906 JEJENOSTOMY FEEDING TUBE Boston Scientific Corp FPD Class II 1997-08-20
K965178 NIAGARA DUAL LUMEN CATHETER Vas-Cath, Inc. MPB Class II 1997-08-19
K971860 MEDISYSTEMS DIALYSIS PRIMING SETS Medisystems Corp. KOC Class II 1997-08-18
K971271 BESECURE EXTERNAL URINARY COLLECTION SYSTEM Urology Research Intl., Inc. KNX Class II 1997-08-18
K971855 POTTY PAL AND FOREVER-DRY Digital Applications, Inc. KPN Class II 1997-08-18
K971937 CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE Terumo Medical Corp. OCY Class II 1997-08-15
K972674 WILSON-COOK NEEDLE KNIFE PAPILLOTOME Wilson-Cook Medical, Inc. KNS Class II 1997-08-15
K970849 ENTERAL NUTRITION 1000 ML/500ML Medical Infusion Technologies, Inc. KNT Class II 1997-08-15
K963668 MEDISYSTEMS PERITONEAL DIALYSIS SETS Medisystems Corp. KDJ Class II 1997-08-15
K972054 INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE Empi KPI Class II 1997-08-14
K964738 ELPHA 2000 CONTI Dan Med, Inc. KPI Class II 1997-08-14
K971977 KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc. FBN Class II 1997-08-12
K971881 COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS Comeg Endoscopy FJL Class II 1997-08-12
K971796 LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS Louisville Laboratories, Inc. EZL Class II 1997-08-12
K971850 SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES Smith & Nephew, Inc. GCJ Class II 1997-08-12
K971982 KARL STORZ MODEL 203020 20 EQUIMAT KARL STORZ Endoscopy-America, Inc. LJH Class II 1997-08-12
K964219 ZIP CONDOM CATHETER Goulter Medical, Inc. EYZ Class I 1997-08-11
K972504 MVM 3.3 MM MICROENDOSCOPE KARL STORZ Endoscopy-America, Inc. GCJ Class II 1997-08-11
K971738 ENDOPATH RESPOSABLE TROCAR SYSTEM Ethicon Endo-Surgery, Inc. GCJ Class II 1997-08-07
K970962 JMS AV FISTULA NEEDLE Jms Co., Ltd. FIE Class II 1997-08-07
K964804 FLEXILOG LS Oakfield Instruments, Ltd. KLA Class II 1997-08-06
K971929 AMSINO URINARY LEG BAG Amsino Intl., Inc. KNX Class II 1997-08-06
K971939 SMITH & NEPHEW SUTURE COLLET Smith & Nephew Endoscopy, Inc. OCW Class II 1997-08-06
K971992 UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) Uromed Corp. FHA Class I 1997-08-01
K965001 INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR Intuitive Surgical, Inc. GCJ Class II 1997-07-31
K972100 VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) Advanced Care Medical Products EXJ Class I 1997-07-31
K972056 STANDARD ENDOSCOPE Laser-Optik-Systeme GmbH & Co. KG GCJ Class II 1997-07-30
K971687 HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME National Medical Care, Inc. FJK Class II 1997-07-29

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