meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
40
Latest Decision
1998-12-18

Clearances · page 55 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980823 CORDIS NITINOL STENT AND DELIVERY SYSTEM Cordis Corp. FGE Class II 1998-12-18
K983623 MODULAP Atc Technologies, Inc. GCJ Class II 1998-12-18
K983293 AUTO SUTURE LAPAROSCOPES DEVICE United States Surgical, A Division of Tyco Healthc GCJ Class II 1998-12-16
K983561 FUJINON EVL-F VIDEO LAPROSCOPE Fujinon, Inc. GCJ Class II 1998-12-16
K983498 BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE C.R. Bard, Inc. FAD Class II 1998-12-15
K983765 INJECTION NEEDLE PROBE/DEVICE-TUNIS Ximed/Prosure/Injectx FBK Class II 1998-12-11
K983628 XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 Richard Wolf Medical Instruments Corp. GCT Class II 1998-12-11
K981253 ULTRACON ULTRAFILTRATOR Interpore Intl. FJI Class II 1998-12-11
K983187 MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE Medsol Corp. KNW Class II 1998-12-10
K974064 MICRO X RESIDUAL TEST STRIPS Reprocessing Products Corp MSY Class II 1998-12-07
K982275 RAPPORT V.T.D. Owen Mumford USA, Inc. LKY Class II 1998-12-04
K983279 ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE Richard Wolf Medical Instruments Corp. GCJ Class II 1998-12-02
K983415 DELIVERY SHEATH Conway Stuart Medical, Inc. FED Class II 1998-12-01
K981365 MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS Sherwood Medical Co. MSD Class II 1998-11-25
K983008 PERIPHERAL AVE STENT SYSTEM Peripheral Ave FGE Class II 1998-11-25
K983076 MEDISYSTEMS TRANSDUCER PROTECTOR Medisystems Corp. FIB Class II 1998-11-25
K981357 ERCO-VAC Ercons, Inc. LKY Class II 1998-11-24
K981343 ERCO-RIBBON Ercons, Inc. LKY Class II 1998-11-24
K983325 IN-PROBE II URODYNAMIC SYSTEM Influence, Inc. FEN Class II 1998-11-24
K980492 AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) Circon Acmi FFK Class II 1998-11-17
K980182 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Usfilter/Ionpure, Inc. FIP Class II 1998-11-16
K973171 NIR BILIARY STENT Medinol, Ltd. FGE Class II 1998-11-13
K983085 HEMOCOR HPH 700 HEMOCONCENTRATOR Minntech Corp. KDI Class II 1998-11-13
K973322 DIAPACT CRRT B.Braun Medical, Inc. KDI Class II 1998-11-10
K983538 MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY Solos Endoscopy, Inc. GCJ Class II 1998-11-06
K983218 N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE Avid N.I.T., Inc. FCG Class II 1998-11-06
K982813 NATURALYTE, MODEL # 08-4004-1 Kaybath, Inc. KPO Class II 1998-11-06
K980129 INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) Richard Wolf Medical Instruments Corp. GCJ Class II 1998-11-05
K982760 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare KDI Class II 1998-11-04
K983206 SMALL VAGINAL/RECTAL ELECTRODE Empi KPI Class II 1998-11-03
K983101 BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 C.R. Bard, Inc. MJC Class II 1998-11-03
K983246 POS-T-VAC (IVP-600) Pos-T-Vac, Inc. LKY Class II 1998-11-02
K983245 POS-T-VAC (AVP-1000) Pos-T-Vac, Inc. LKY Class II 1998-11-02
K982970 MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER Mri Manufacturing and Research, Inc. EZL Class II 1998-10-28
K982890 ADVANCED UROSCIENCE INJECTION NEEDLE Advanced Uroscience, Inc. FBK Class II 1998-10-26
K982013 MGB LAPALUX TELESCOPE Mgb Endoskopische Gerate GmbH GCJ Class II 1998-10-21
K982508 FLEXIMA Boston Scientific Corp FGE Class II 1998-10-16
K981323 COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE Novartis Nutrition Corp. KNT Class II 1998-10-09
K981591 VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT International Regulatory Consultants FAD Class II 1998-10-09
K982412 MODIFICATION OF CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. MQS Class II 1998-10-09
K982417 INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP Innerdyne, Inc. GCJ Class II 1998-10-07
K980906 TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO Transonic Systems, Inc. MQS Class II 1998-10-06
K982905 MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE Karl Storz Endoscopy FGB Class II 1998-10-05
K982734 OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE The Olympus Optical Co. ODG Class II 1998-10-05
K982620 MEDIVISION CYSTOSCOPE Medivision Scope Service Center, Inc. FAJ Class II 1998-09-30
K982623 AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM Aesculap, Inc. GCJ Class II 1998-09-30
K981940 MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES Dexide, Inc. GCJ Class II 1998-09-25
K982960 MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT Medical Device Technologies, Inc. KNW Class II 1998-09-23
K982962 XENON LIGHT SOURCE, MODELS LS6180, LS6035 Contec Medical Vision, Ltd. GCT Class II 1998-09-23
K974899 GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H Gambro Healthcare FIP Class II 1998-09-23
K982542 STRYKER URETERAL ILLUMINATOR SYSTEM III Stryker Endoscopy FCS Class II 1998-09-22
K983017 MODIFICATION TO SYSTEM 83 PLUS Custom Ultrasonics NVE Class II 1998-09-22
K982073 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM Anchor Products Co. GCJ Class II 1998-09-22
K973076 EUROMEDICAL HAEMATURIA FOLEY CATHETER Unomedical Sdn Bhd EZL Class II 1998-09-16
K970700 FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX Fresenius USA, Inc. MSE Class II 1998-09-15
K982462 FIBER OPTIC ENDOILLUMINATION PROBE Microvision, Inc. FFS Class II 1998-09-14
K982894 MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT Ballard Medical Products KNT Class II 1998-09-11
K982557 BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES Bard Interventional Products Div. KNS Class II 1998-09-10
K982735 LIGHT SABER BONE BIOPSY NEEDLE Minrad, Inc. KNW Class II 1998-09-09
K982445 MODULAP Atc Medical Technology, Inc. GCJ Class II 1998-09-08
K982401 PROSTATE BIOPSY NEEDLE Remington Medical, Inc. KNW Class II 1998-09-08
K981999 ALBATECH PERSONAL MONITOR Albatech, Inc. GCJ Class II 1998-09-04
K981994 VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER C.R. Bard, Inc. MSD Class II 1998-09-03
K982005 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. FGE Class II 1998-09-02
K981180 REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT Pos-T-Vac, Inc. LKY Class II 1998-08-28
K981011 POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) Pos-T-Vac, Inc. LKY Class II 1998-08-28
K974090 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS Fresenius Medical Care North America MSE Class II 1998-08-27
K973943 INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER Richard Wolf Medical Instruments Corp. GCJ Class II 1998-08-27
K982378 HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE Solution Technologies KPO Class II 1998-08-26
K981993 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA The Olympus Optical Co. ODA Class II 1998-08-21
K982626 URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 Medworks Corp. EZL Class II 1998-08-20
K982289 HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## Olympus America, Inc. KNS Class II 1998-08-19
K971434 A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE Applied Medical Technologies KNT Class II 1998-08-17
K982465 DEROYAL INDUSTRIES, INC. DEFOGGER Deroyal Industries, Inc. OCT Class II 1998-08-11
K981681 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Gambro Healthcare KDI Class II 1998-08-11
K982287 ASLAN SENSOR MODULAR INSTRUMENT Aslan Medical Technologies, Ltd. GCJ Class II 1998-08-06
K981928 GALILEO DISPOSABLE ENDOSCOPES Galileo Electro-Optics Corp. GCJ Class II 1998-08-06
K980868 GC IRRIGATOR Gentle Colonics, Inc. KPL Class II 1998-08-06
K981796 LIGHT SABER CORE TISSUE NEEDLE Minrad, Inc. KNW Class II 1998-08-05
K981889 WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE Worldwide Medical Technologies, LLC FCG Class II 1998-07-31
K981611 SNAP-N-PEEL INTRODUCERS Circon Corp. KNY Class II 1998-07-30
K981856 MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) Greatbatch Scientific FET Class II 1998-07-29
K981941 MULTAPORT CANNULA REDUCER AND ACCESSORIES Dexide, Inc. GCJ Class II 1998-07-29
K981721 C0-AXIAL INTRODUCER NEEDLE Inrad KNW Class II 1998-07-28
K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM Angiolaz, Inc. FET Class II 1998-07-28
K981804 XENON LIGHT SOURCE MODEL LS6000 Contec Medical Vision, Ltd. GCT Class II 1998-07-24
K970681 ALTRA NOVA 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl MSF Class II 1998-07-23
K970679 ALTRA FLUX 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl MSF Class II 1998-07-23
K980290 ITI STENT Intratherapeutics, Inc. FGE Class II 1998-07-21
K982085 MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT Medical Device Technologies, Inc. KNW Class II 1998-07-17
K973430 KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM Eastman Kodak Company GCJ Class II 1998-07-17
K974040 C3 EXTERNAL MALE BLADDER CONTROL DEVICE Timm Research Co. FHA Class I 1998-07-14
K980787 HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR Computer Motion, Inc. GCJ Class II 1998-07-13
K981531 SUTURE PLACEMENT DEVICE AND ACCESSORIES Lsi Solutions GCJ Class II 1998-07-13
K974652 BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER Baxter Healthcare Corp KDI Class II 1998-07-10
K981612 ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER Rochester Medical Corp. EZL Class II 1998-07-08
K981615 KSEA UROPUMP KARL STORZ Endoscopy-America, Inc. LJH Class II 1998-07-08
K981301 SPEED-CUT AUTOMATIC BIOPSY SYSTEM Gallini U.S., LLC KNW Class II 1998-07-08
K981294 ODYSSEY INSTRUMENTATION SYSTEM Automata Instrumentation, Inc. FIZ Class II 1998-07-08
K972328 PERCUTANEOUS BREAST BIOPSY (PBB) Urothealth System, Inc. KNW Class II 1998-07-07

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