meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
51
Latest Decision
2000-03-03

Clearances · page 52 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K000197 CORTEK CYSTOSCOPE Cortek Endoscopy, Inc. FAJ Class II 2000-03-03
K994348 KSEA SCB-RUI KARL STORZ Endoscopy-America, Inc. FET Class II 2000-03-03
K993604 ENDOSCOPIC ANTI FOG DEVICE Mectra Labs, Inc. OCT Class II 2000-03-03
K994087 SUPERSTITCH Sutura, Inc. OCW Class II 2000-03-01
K992715 NEURO URODYNAMIC SUITE, MODEL 9032E0101 Medtronic Functional Diagnostics A/S FEN Class II 2000-02-28
K993976 PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR The Prometheus Group KPI Class II 2000-02-22
K993951 SPOT ENDOSCOPIC MARKER Chek-Med Systems NBG Class II 2000-02-18
K000070 FLOCATH Rusch Intl. KOD Class II 2000-02-18
K993436 CAVERMAP SURGICAL AID Uromed Corp. FGM Class I 2000-02-11
K993704 GASTRO-INTESTINAL SYSTEM EN-410WM Fujinon, Inc. FDA Class II 2000-02-11
K994300 NASOGASTRIC TUBE HOLDER, MODEL 160 Dale Medical Products, Inc. KNT Class II 2000-02-10
K994218 EASY CARE AND TUBING SETS Medionics International, Inc. FKX Class II 2000-02-10
K992039 EXEL I.V. BLOOD LINE SET Exelint Intl. Co. FJK Class II 2000-02-10
K992930 BIOTEQUE HEMODIALYSIS BLOOD TUBING SET Bioteque Corp. FJK Class II 2000-02-09
DEN000002 UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE Urosurge, Inc. NAM Class II 2000-02-09
K994090 KARL STORZ AUTOCLAVABLE CAMERA HEAD Karl Storz Imaging, Inc. FET Class II 2000-02-04
K994256 SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 A & A Medical, Inc. GCJ Class II 2000-02-03
K993904 INTRASTENT DOUBLESTRUT LD Intratherapeutics, Inc. FGE Class II 2000-02-01
K993840 BARD UROFORCE BALLOON DILATION CATHETER C.R. Bard, Inc. EZN Class II 2000-01-31
K993906 NANMA NON-ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. LKY Class II 2000-01-31
K993908 NANMA AJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. LKY Class II 2000-01-31
K993200 MD 420/440/460/470/480/490 Isopure, Corp. FIP Class II 2000-01-24
K992786 PURE WATER, INC.'S WATER PURIFICATION SYSTEMS Pure Water, Inc. FIP Class II 2000-01-24
K993058 PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL Pure Water, Inc. FIN Class II 2000-01-24
K994066 MTP DISPOSABLE TROCARS Mtp Medical Technical Promotion GmbH GCJ Class II 2000-01-20
K993587 HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. MQS Class II 2000-01-20
K994084 SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES Smith & Nephew, Inc. FFS Class II 2000-01-20
K992563 A-22 HEMODIALYZER Althin Medical AB KDI Class II 2000-01-18
K992573 AF-220 HEMODIALYZER Althin Medical AB KDI Class II 2000-01-18
K993720 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER Cordis Corp. KNQ Class II 2000-01-18
K992564 AF-180 HEMODIALYZER Althin Medical AB KDI Class II 2000-01-18
K992566 AF-150 HEMODIALYZER Althin Medical AB KDI Class II 2000-01-18
K991916 VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Virginia Water Systems, Inc. FIP Class II 2000-01-14
K992941 LEMAITRE BILIARY CATHETER Vascutech, Inc. LQR Class II 2000-01-12
K992719 AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE Amsino Intl., Inc. KNT Class II 2000-01-12
K992016 AMUKIN D Amuchina Intl., Inc. LIF Class II 2000-01-10
K994156 MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B Cordis Corp. FGE Class II 2000-01-07
K994272 AUTOMATED CORE BIOPSY DEVICE Promex, Inc. KNW Class II 2000-01-07
K990803 MEDISYSTEMS BUTTONHOLE NEEDLE SETS Medisystems Corp. FIE Class II 2000-01-06
K993738 DISPOS-A-SCOPE Dispos-A-Scope FER Class II 2000-01-06
K993778 HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 Northgate Technologies, Inc. OCX Class II 2000-01-06
K993892 DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 C.R. Bard, Inc. FGE Class II 2000-01-06
K993392 BARD MEMOTHERM FLEXX BILIARY STENT C.R. Bard, Inc. FGE Class II 2000-01-06
K993330 THERMOCHEM-HT SYSTEM Hemocleanse, Inc. MLW Class II 1999-12-30
K993232 WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Scimed, Inc. FGE Class II 1999-12-30
K993650 URETERAL ACCESS SHEATH SET - NEW MODELS Applied Medical Resources FED Class II 1999-12-28
K993936 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE Imagyn Surgical KNW Class II 1999-12-27
K993142 ELITE CUSTOM Soma Blue, Inc. LKY Class II 1999-12-27
K993143 VITALITY SYSTEM Soma Blue, Inc. LKY Class II 1999-12-27
K994166 GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE Gyrus Medical , Ltd. KNS Class II 1999-12-27
K994068 S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 1999-12-23
K993651 O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER Sc Hennig Enterprises Europe Srl GBM Class II 1999-12-23
K993342 DUCPREP BREAST ASPIRATOR, MODEL PMPO2 Windy Hill Technology, Inc. KNW Class II 1999-12-23
K992402 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH Telemed Systems, Inc. KNS Class II 1999-12-22
K992390 HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD Telemed Systems, Inc. KGE Class II 1999-12-22
K993544 SPACE-OR RETRACTOR Advanced Surgical Concepts (Asc) FFO Class I 1999-12-22
K993118 BIOTEQUE A.V. FISTULA NEEDLE SET Bioteque Corp. FIE Class II 1999-12-17
K993689 AED CYSTOSCOPE National Advanced Endoscopy Devices, Inc. FAJ Class II 1999-12-15
K993296 TRIP TONOMETRY CATHETER, 14F Datex-Ohmeda, Inc. KNT Class II 1999-12-15
K993103 ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES Richard Wolf Medical Instruments Corp. GCM Class II 1999-12-10
K993226 MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 Memcath Technologies, LLC EZD Class II 1999-12-10
K992209 CUSTODIOL Dr. Franz Kohler Chemie GmbH KDN Class II 1999-12-10
K993464 BARDEX I.C. PEDIATRIC FOLEY CATHETER C.R. Bard, Inc. MJC Class II 1999-12-10
K993063 RUSCH BRILLANT SILICONE FOLEY Rusch Intl. EZL Class II 1999-12-09
K990643 PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1999-12-07
K984168 BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE United States Endoscopy Group, Inc. FCF Class II 1999-12-07
K993445 OMNISONIC ENDOSCOPIC DEFLECTOR Omnisonics Medical Technologies GCM Class II 1999-12-06
K993435 MANUAL BONE MARROW BIOPSY DEVICE Promex, Inc. KNW Class II 1999-12-06
K993688 AED LAPAROSCOPE National Advanced Endoscopy Devices, Inc. GCJ Class II 1999-12-06
K992255 CKHEMO, MODEL CKHEMO VERSION 1.0 Csam, Inc. FKP Class II 1999-11-30
K993721 UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES Laborie Medical Tech Corp. KPI Class II 1999-11-29
K993646 S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 1999-11-28
K990808 PBN DILATORS Medical Device Technologies, Inc. FGE Class II 1999-11-26
K992894 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 Baxter Healthcare Corp KDI Class II 1999-11-24
K993046 FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 Fibra Sonics, Inc. FEO Class II 1999-11-22
K992852 SUTURE CLINCH Applied Medical Resources GCJ Class II 1999-11-22
K992813 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT Ethicon Endo-Surgery, Inc. KNW Class II 1999-11-18
K983239 WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS Rasco FIP Class II 1999-11-18
K993588 MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, Guidant Corp. FGE Class II 1999-11-17
K992793 SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM Better Water, Inc. FIN Class II 1999-11-16
K991320 MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN Medical Components, Inc. MPB Class II 1999-11-10
K992713 POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 Medtronic Functional Diagnostics A/S FFX Class II 1999-11-10
K993300 COLDLIGHTSOURCE PL3000 Fiber Imaging Technologies, Inc. FCW Class II 1999-11-05
K990229 HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 Justec Medical Products, Inc. KDN Class II 1999-11-04
K991672 OLYMPUS NA-10J-KB ASPIRATION NEEDLE Olympus America, Inc. FCG Class II 1999-11-03
K993091 PALMAZ XL TANSHEPATIC BILIARY STENTS Cordis Corp. FGE Class II 1999-10-29
K991918 NUTRISAFE EXTENSION TUBE Vygon Corp. KNT Class II 1999-10-29
K992653 SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. FIE Class II 1999-10-27
K993045 BARIATRIC LAPAROSCOPE, MODEL 367 Stryker Endoscopy GCJ Class II 1999-10-27
K993212 DRYASOL ACID CONCENTRATE MIX Diasol, Inc. KPO Class II 1999-10-22
K993145 MEDTRONIC AVE BRIDGE STENT Medtronic Ave, Inc. FGE Class II 1999-10-21
K992447 50 W METAL HALIDE ILLUMINATOR, VES 0501. Angiolaz, Inc. FCW Class II 1999-10-20
K993138 BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT Ballard Medical Products KNT Class II 1999-10-20
K992469 KSEA SCBCOM Karl Storz Endoscopy FET Class II 1999-10-15
K992816 MODIFICATION TO INTRASTENT Intratherapeutics, Inc. FGE Class II 1999-10-15
K992612 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 Ethicon Endo-Surgery, Inc. GCJ Class II 1999-10-14
K992431 NEO-2 METER Automata Instrumentation, Inc. FIZ Class II 1999-10-13
K992527 URETERO-RENOSCOPE Fiber Imaging Technologies, Inc. FGB Class II 1999-10-13
K992319 RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM Guidant Corp. FGE Class II 1999-10-08
K992983 BAHO AUTOCLAVABLE CYSTOSCOPE Innovative Endoscopy Components, LLC FAJ Class II 1999-10-07

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