meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
49
Latest Decision
2004-08-27

Clearances · page 42 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041428 ACCUSOL DIALYSIS SOLUTION Baxter Healthcare Corp KPO Class II 2004-08-27
K031502 USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM Usfilter FIN Class II 2004-08-27
K041683 B. BRAUN BICARBONATE DIALYSATE B.Braun Medical, Inc. KPO Class II 2004-08-27
K040476 STORZ MODULITH, MODEL SLX-F2 KARL STORZ Endoscopy-America, Inc. LNS Class II 2004-08-26
K041573 NANMA VACUUM PUMP PROXZEK MODEL 2M9498S Nanma Mfg Co., Ltd. LKY Class II 2004-08-25
K042204 MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3, Inc. FGE Class II 2004-08-23
K040741 ULTRASOUND LOCALIZATION SYSTEM ULS 0142 Hmt High Medical Technologies AG LNS Class II 2004-08-19
K041610 MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 Richard Wolf Medical Instruments Corp. FJL Class II 2004-08-19
K042140 OLYMPUS BF TYPE UC160-OL8 Olympus Corporation ODG Class II 2004-08-18
K032975 JMS BLOOD TUBING SETS Jms North America Corp. FJK Class II 2004-08-16
K033135 STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM Stryker Endoscopy KNS Class II 2004-08-09
K033648 PERFORMANCE WATER TREATMENT SYSTEM Performance Water Systems, LLC FIP Class II 2004-08-09
K041827 DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 Boston Scientific Corp GCJ Class II 2004-08-06
K041796 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corporation FGE Class II 2004-08-03
K041559 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 Spire Biomedical, Inc. MSD Class II 2004-07-30
K040992 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 Medcomp MSD Class II 2004-07-29
K041726 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX Asahi Medical Co., Ltd. KDI Class II 2004-07-23
K041544 COOK SIDEARM CORE TISSUE BIOPSY DEVICE Urological, Inc. KNW Class II 2004-07-22
K041423 VIABIL BILIARY ENDOPROSTHESIS W. L. Gore & Associates, Inc. FGE Class II 2004-07-21
K040897 DOVER ROB-NEL CATHETER Tyco Healthcare KOD Class II 2004-07-20
K040266 CORE NEEDLE BIOPSY Remington Medical, Inc. KNW Class II 2004-07-09
K040961 INJECTOR NEEDLE/SNARE United States Endoscopy Group, Inc. FDI Class II 2004-07-08
K041243 DOVER RED RUBBER ROBINSON CATHETER Tyco Healthcare KOD Class II 2004-07-07
K041606 EXTRACTOR RX RETRIEVAL BALLOON Boston Scientific Corp FGE Class II 2004-07-07
K041582 MODIFICATION TO TRIPTER X-1 COMPACT DUET Direx Systems Corp. LNS Class II 2004-07-07
K040237 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. NAY Class II 2004-07-07
K041424 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. KDI Class II 2004-07-02
K041416 EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER Deroyal EYC Class II 2004-07-02
K040930 ZILVER BILIARY STENT SYSTEM USW Wilson-Cook Medical, Inc. FGE Class II 2004-07-02
K041636 H&S-CONDUCTIVITY STANDARD SOLUTION H & S Technical Services FKH Class II 2004-07-02
K041494 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 Olympus Corporation FET Class II 2004-07-01
K041641 DAVOL DELIVERY SYSTEM C.R. Bard, Inc. GCJ Class II 2004-07-01
K033118 BIPRO MODEL SDS-CB200 Medical Solutions International FIN Class II 2004-06-28
K040800 WILOSN-COOK BILIARY DILATION BALLOON Wilson-Cook Medical, Inc. FGE Class II 2004-06-25
K041370 LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2004-06-24
K040494 CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 United States Endoscopy Group, Inc. NEZ Class II 2004-06-23
K041108 ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA Iscience Surgical Corporation MPA Class II 2004-06-22
K040413 CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM Cordis Europa, N.V. FGE Class II 2004-06-21
K040836 DISPOSABLE OVERTUBE United States Endoscopy Group, Inc. FED Class II 2004-06-10
K033477 HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT Rochester Medical Corp. MJC Class II 2004-06-10
K040048 FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM Fujinon, Inc. FDA Class II 2004-06-07
K040604 INNERVUE DIAGNOSTIC SCOPE SYSTEM Arthrotek, Inc. GCJ Class II 2004-06-04
K040696 MODIFICATION TO NXSTAGE SYSTEM ONE Nxstage Medical, Inc. KDI Class II 2004-05-26
K040461 ECONOLITH E3000, MODEL 3000 (SW-6) Medispec, Ltd. LNS Class II 2004-05-25
K040255 POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE Gambro Renal Products, Inc. KDI Class II 2004-05-24
K040324 WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH Wilson-Cook Medical, Inc. FDX Class II 2004-05-20
K040520 SLIP UROLOGY INTRODUCER SHEATH Percutaneous Systems, Inc. KNY Class II 2004-05-20
K040519 SLIP UROLOGY CATHETER Percutaneous Systems, Inc. EZD Class II 2004-05-20
K041006 TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR Kendall MSD Class II 2004-05-19
K040736 VAXCEL PLUS CHRONIC DIALYSIS CATHETER Boston Scientific Corp MSD Class II 2004-05-18
K040388 NEXT GENERATION SALEM SUMP Kendall FEG Class II 2004-05-17
K040666 STEP-TIP CHRONIC HEMODIALYSIS CATHETER Arrow International, Inc. MSD Class II 2004-05-14
K040504 BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS C.R. Bard, Inc. EZL Class II 2004-05-14
K041131 APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR Apple Medical Corp. GCJ Class II 2004-05-13
K030413 Y2K2 ENTERNAL FEEDING MANAGER Moss Medical Products KNT Class II 2004-05-11
K041032 MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2004-05-10
K040949 VIADUCT MINISCOPE AND ACCESSORIES Acueity, Inc. GCT Class II 2004-05-07
K040981 USW NEEDLEKNIFE PAPILLOTOME Wilson-Cook Medical, Inc. KNS Class II 2004-05-07
K040893 EASY CORE BIOPSY SYSTEM Boston Scientific Corp FCG Class II 2004-05-06
K040948 INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 Intuitive Surgical, Inc. NAY Class II 2004-05-05
K040842 SENORX BIOPSY DEVICE II Senorx, Inc. KNW Class II 2004-04-30
K040653 PARAMOUNT MINI GPS BILIARY STENT SYSTEM Ev3, Inc. FGE Class II 2004-04-28
K040470 TRIPTER X-1 COMPACT Direx Systems Corp. LNS Class II 2004-04-28
K031457 ENDOMAT LC PUMP, MODEL 20 3303 20 KARL STORZ Endoscopy-America, Inc. OCX Class II 2004-04-28
K033505 RENACLEAN SH DIALYZER CLEANING SYSTEM Minntech Corp. LIF Class II 2004-04-27
K040489 AQUADEX SYSTEM 100, MODEL A1100 Chf Solutions, Inc. KDI Class II 2004-04-27
K040402 ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. MSD Class II 2004-04-19
K040509 ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 Spire Biomedical, Inc. MSD Class II 2004-04-19
K030366 BICARD MIXING SYSTEM Dialysis Systems, Inc. FIN Class II 2004-04-19
K040215 VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM Vision-Sciences, Inc. FAJ Class II 2004-04-15
K040094 PIGGYBACK IRRIGATING SYSTEM Kosin Technologies, LLC LJH Class II 2004-04-15
K040074 ONEVIEW INTERFACE Nxstage Medical, Inc. FKP Class II 2004-04-08
K032734 CONVATEC FECAL MANAGEMENT SYSTEM Convatec, A Bristol-Myers Squibb Co. KNT Class II 2004-04-08
K040667 XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 Abbott Laboratories FGE Class II 2004-04-07
K040127 COOK URETERAL BALLOON DILATION CATHETER SET Cook Urological, Inc. EZN Class II 2004-04-06
K023064 HEMOCLEAN Krd Co., Ltd. NII Class II 2004-04-06
K032794 CUSTODIOL Dr. Franz Kohler Chemie GmbH MSB Class II 2004-04-05
K030784 NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL Applied Medical Technology, Inc. KNT Class II 2004-04-01
K040087 RABBIT Scion International, Inc. KNW Class II 2004-04-01
K040027 BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM Boston Scientific FGE Class II 2004-03-30
K040110 EASY LOOP, MODEL EZL-01 Tools For Surgery, LLC EZP Class II 2004-03-24
K033644 ENDOBOY Geyser S.A. GCJ Class II 2004-03-24
K040244 MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 The Microoptical Corporation GCJ Class II 2004-03-24
K033149 ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM Ultimate Concepts, Inc. KPL Class II 2004-03-23
K031084 SOLAR GI SYSTEM Medical Measurement Systems B.V. FFX Class II 2004-03-19
K033954 SHAPE LOCKING ENDOSCOPIC OVERTUBE Usgi Medical, Inc. FED Class II 2004-03-19
K040492 VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER Boston Scientific Corp MSD Class II 2004-03-16
K040505 ZILVER 635 BILIARY STENT Cook, Inc. FGE Class II 2004-03-16
K040550 LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2004-03-16
K040447 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 Boston Scientific Corp LQC Class II 2004-03-12
K033191 SOHNIKS Sohniks Endoscopy, Inc. FAJ Class II 2004-03-09
K032688 COLONOSIGHT MODEL 510B Sightline Technologies , Ltd. FDF Class II 2004-03-05
K040260 INTEGRAL HEMODIALYSIS CATHETER Arrow Int'L. MSD Class II 2004-03-05
K033249 PAJUNK MODULAR HANDLE INSTRUMENTS Pajunk GmbH GCJ Class II 2004-03-05
K033842 NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE Vernon-Carus Limited GCJ Class II 2004-03-04
K040247 PLUME SAFETY AVF NEEDLE Jms North America Corp. FIE Class II 2004-03-03
K034066 B.BRAUN PREMIXED DIALYSATE B.Braun Medical, Inc. KPO Class II 2004-03-03
K032840 ATRION MEDICAL QL INFLATION DEVICE Atrion Medical Products, Inc. KOE Class II 2004-03-03
K033616 TRAPMATIC SYSTEM SET H.S Hospital Service S.P.A KNW Class II 2004-03-01
K040129 TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING Wilson-Cook Medical, Inc. GCA Class II 2004-02-27

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