meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
42
Latest Decision
2004-02-27

Clearances · page 43 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033330 CONDUCTIVITY/TDS CALIBRATOR SOLUTION Mesa Laboratories, Inc. FKH Class II 2004-02-27
K033676 PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER Kendall MSD Class II 2004-02-20
K040151 OASIS BILIARY STENT INTRODUCTION SYSTEM Wilson-Cook Medical, Inc. FGE Class II 2004-02-20
K033700 MAMMOTOME EX HAND HELD SYSTEM Ethicon Endo-Surgery, Inc. KNW Class II 2004-02-20
K040137 WILSON-COOK USW CAP AND WIRE LOCK Wilson-Cook Medical, Inc. OCY Class II 2004-02-20
K033909 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories FGE Class II 2004-02-17
K040248 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2004-02-17
K032958 PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 United Medical Systems, Inc. LNS Class II 2004-02-17
K040078 CANNON II PLUS Arrow International, Inc. MSD Class II 2004-02-13
K031492 MOSSMED DUAL INTERMITTENT ASPIRATOR Moss Medical Products KNT Class II 2004-02-05
K033719 BARD TIGERTAIL URETERAL CATHETER C.R. Bard, Inc. KOD Class II 2004-02-04
K030293 AMSURE RED RUBBER URETHRAL CATHETER Amsino International, Inc. EYB Class II 2004-02-04
K032436 DURAMAX .018 BILIARY STENT SYSTEM Avantec Vascular Corp. FGE Class II 2004-02-04
K033497 BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. Bard, Inc. FGE Class II 2004-02-04
K033651 OLYMPUS VIDEO URETEROSCOPE, NTSC Olympus Winter & Ibe GmbH FGB Class II 2004-01-30
K034064 FRESENIUS ULTRAFLO HPX HEMODIALYZER Fresenius Medical Care North America KDI Class II 2004-01-30
K031617 MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER Mediplus , Ltd. KLA Class II 2004-01-16
K033936 BARD ELIMINATOR PET BALLOON DILATORS C.R. Bard, Inc. KNQ Class II 2004-01-14
K031147 OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR Ethicon Endo-Surgery, Inc. KNQ Class II 2004-01-12
K033830 OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 Opticon Medical, Inc. EZL Class II 2004-01-09
K032710 CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT Apogee Medical, Inc. KOD Class II 2004-01-09
K033834 OMNILINK .018 BILIARY STENT SYSTEM Guidant Corp. FGE Class II 2004-01-02
K033256 ATHENA PELVIC MUSCLE TRAINER II Athena Feminine Technologies, Inc. KPI Class II 2003-12-30
K033317 SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 Opus Medical, Inc. OCW Class II 2003-12-30
K033778 MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. Bard, Inc. FED Class II 2003-12-30
K033754 TRACER METRO SMART WIRE GUIDE Wilson-Cook Medical, Inc. OCY Class II 2003-12-30
K032127 HEMEDEX FIXATION DEVICE Hemedex Incorporated KNY Class II 2003-12-30
K031267 STERICHEK BICARB PH REAGENT STRIPS Environmental Test Systems, Inc. MNV Class II 2003-12-23
K033695 IRRIGATION CHANNEL TUBING, MODEL 100135 Byrne Medical, Inc. OCX Class II 2003-12-23
K032061 DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH Spire Biomedical, Inc. MSD Class II 2003-12-23
K031689 DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) Chf Solutions, Inc. NQJ Class II 2003-12-23
K033023 INTERMITTENT URETHRAL CATHETERS Rusch Intl. KOD Class II 2003-12-23
K033394 CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp. FGE Class II 2003-12-22
K033203 WILSON-COOK TRI-TOME SELECT PLUS Wilson-Cook Medical, Inc. KNS Class II 2003-12-19
K033359 DEGALL II GALLBLADDER EXTRACTOR Surgicon, Inc. GCJ Class II 2003-12-19
K032943 STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS Stryker Corp. KNW Class II 2003-12-17
K033348 ZILVER 518 BILIARY STENT Cook, Inc. FGE Class II 2003-12-15
K031169 MOTILITY VISUALIZATION SYSTEM Sierra Scientific Instruments, Inc. FFX Class II 2003-12-12
K033562 FASTRAC GASTRIC ACCESS PORT KIT C.R. Bard, Inc. KNT Class II 2003-12-12
K033537 SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 Abbott Laboratories FGE Class II 2003-12-10
K033269 ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD Ethicon Endo-Surgery, Inc. OCW Class II 2003-12-10
K023023 LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA Vasca, Inc. MSD Class II 2003-12-04
K032988 ELPHA 4 CONTI Danmeter A/S KPI Class II 2003-12-03
K033386 NXSTAGE PUREFLOW SOLUTION Nxstage Medical, Inc. KPO Class II 2003-11-26
K033368 FOSSA URETERAL OPEN LUMEN STENT Fossa Medical, Inc. EYB Class II 2003-11-26
K033294 HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER C.R. Bard, Inc. MSD Class II 2003-11-26
K033335 LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS Siemens Medical Solutions USA, Inc. MMZ Class II 2003-11-25
K032598 SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. MPA Class II 2003-11-24
K033314 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. FGE Class II 2003-11-21
K033593 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS Clearmedical, Inc. NLU Class II 2003-11-20
K023874 SYSTEM 100 ULTRAFILTRATION CATHETER Chf Solutions, Inc. KDI Class II 2003-11-20
K031676 HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q Baxter Healthcare Corp KDJ Class II 2003-11-20
K033134 MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM Ev3, Inc. FGE Class II 2003-11-17
K011261 STONE EXTRACTOR BALLOON CATHETER Medi-Globe Corp. FGE Class II 2003-11-17
K033333 SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B Aomori Olympus Co., Ltd. FGE Class II 2003-11-14
K031236 AUTO-BAND LIGATOR Scandimed. A.S. MND Class II 2003-11-14
K032521 BARD DUAL LUMEN URETERAL CATHETER C.R. Bard, Inc. EYB Class II 2003-11-14
K033393 ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM Guidant Corp. FGE Class II 2003-11-10
K033427 MODIFICATION TO EN-BLOC BIOPSY SYSTEM Neothermia Corp. KNW Class II 2003-11-10
K033245 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. Bard, Inc. MND Class II 2003-11-06
K032676 ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR Ethicon Endo-Surgery, Inc. GCJ Class II 2003-10-30
K023509 DBB-05 HEMODIALYSIS DELIVERY SYSTEM Davita Clinical Research (Trri) KDI Class II 2003-10-30
K033212 LIFESTENT SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2003-10-30
K030120 AMSURE FOLEY CATHETER Amsino International, Inc. EZL Class II 2003-10-29
K032405 GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2003-10-29
K032356 NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS Nxstage Medical, Inc. KDI Class II 2003-10-28
K022730 PERFADEX SOLUTION FOR LUNG PRESERVATION Vitrolife AB MSB Class II 2003-10-27
K032820 MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. ODE Class II 2003-10-23
K032530 MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM Guidant Corporation FGE Class II 2003-10-23
K032093 PARIEFIX Sofradim Production GCJ Class II 2003-10-22
K032929 MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 Abbott Vascular, Inc. FGE Class II 2003-10-22
K032580 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. FGE Class II 2003-10-22
K030348 BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE Biolab Equipment Canada , Ltd. FIP Class II 2003-10-21
K031278 STRYKER FLEXIBLE URETEROSCOPE Stryker Endoscopy FGB Class II 2003-10-16
K032506 SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM Sanarus Medical, Inc. KNW Class II 2003-10-09
K030472 MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM Ethicon Endo-Surgery, Inc. KNW Class II 2003-10-09
K032138 MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER Medtronic Vascular KLA Class II 2003-10-09
K032768 MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) Medtronic Ave, Inc. FGE Class II 2003-10-09
K032776 VACURECT VACUUM CONSTRICTION DEVICE Vacurect Manufacturing (Pty) , Ltd. LKY Class II 2003-10-03
K032712 VAXCEL PLUS CHRONIC DIALYSIS CATHETER Boston Scientific Corp MSD Class II 2003-10-02
K032889 OPTICAL SEPARATOR Applied Medical Resources GCJ Class II 2003-10-02
K032177 GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I Olympus Opto-Electronics Co., Ltd. FDS Class II 2003-10-02
K032004 AQUABOSS ECORO DIA 50 Lauer Ltd., Hong Kong FIP Class II 2003-10-02
K022490 KSEA MEDI PACK KARL STORZ Endoscopy-America, Inc. GCT Class II 2003-09-29
K030050 TORAYSULFONE DIALYZER, BS-L SERIES Toray Industries (America), Inc. KDI Class II 2003-09-29
K024076 MAKY 21.1 DIALYZER REPROCESSING SYSTEM Hdc Maquinolas, LLC LIF Class II 2003-09-26
K032680 SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 Smith & Nephew, Inc. GCJ Class II 2003-09-26
K032847 EXCISOR BIOPTOME, MODEL 01-0004 Acueity, Inc. KNW Class II 2003-09-26
K032025 SENTINOL NITINOL BILLARY STENT SYSTEM Boston Scientific Corp FGE Class II 2003-09-25
K031360 GI SUPPLY BILIARY STENT Gi Supply FGE Class II 2003-09-24
K031895 KSEA OPSERVER LAP KARL STORZ Endoscopy-America, Inc. FET Class II 2003-09-23
K031351 FLEX-NECK PD CATHETER, INFANT Medigroup, Inc. FJS Class II 2003-09-17
K032137 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2003-09-17
K032075 CONDUCTIVITY STANDARD SOLUTION-METERCARE Ibp Instruments GmbH FKH Class II 2003-09-17
K031099 SORB+HISORB+CARTRIDGE Renal Solutions, Inc. FKT Class II 2003-09-17
K031593 SOPRO 61D Sopro GCJ Class II 2003-09-16
K032431 PRISMA M60/M100 SETS Gambro, Inc. KDI Class II 2003-09-15
K031882 ENDOSCOPIC APPLICATOR Baxter Healthcare Corp GCJ Class II 2003-09-05
K032430 ACUEITY MEDICAL LIGHT SOURCE Acueity, Inc. FCW Class II 2003-09-05
K032457 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2003-09-04

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