meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
2005-10-06

Clearances · page 40 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051584 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY Kendall MSD Class II 2005-10-06
K051176 FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 Richard Wolf Medical Instruments Corp. FAJ Class II 2005-10-05
K052134 CYSTOGLIDE DILATING INTRODUCER SHEATH Percutaneous Systems, Inc. KNY Class II 2005-09-22
K052084 ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. FED Class II 2005-09-14
K052048 ACCORDION Percutaneous Systems, Incorporated FFL Class II 2005-09-13
K051585 F-400 SYSTEM Mauna Kea Technologies GCJ Class II 2005-09-06
K051593 UROPASS URETERAL ACCESS SHEATH, MODEL 61224 Acmi Corporation KNY Class II 2005-09-02
K051979 ORS MODEL 6000 ENDOSCOPE HOLDER O.R. Solutions, Inc. OCT Class II 2005-08-30
K051905 UROPLASTY RIGID ENDOSCOPIC NEEDLE Uroplasty, Inc. FBK Class II 2005-08-29
K052114 BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP Bard Peripheral Vascular, Inc. FGE Class II 2005-08-25
K052132 MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM Edwards Lifesciences, LLC FGE Class II 2005-08-24
K052194 SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR Boston Scientific Corp ODF Class II 2005-08-24
K051785 FORMULA 418 BILIARY STENT Cook, Inc. FGE Class II 2005-08-23
K050827 NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) Dialysis Solutions, Inc. KPO Class II 2005-08-22
K051344 COLONIC AND ENEMA NOZZLE Ultimate Concepts, Inc. KPL Class II 2005-08-18
K052044 ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL Acmi Corporation FGB Class II 2005-08-16
K051613 MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 Olympus Medical Systems Corporation ODA Class II 2005-08-15
K051748 HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS C.R. Bard, Inc. MSD Class II 2005-08-12
K051732 ENDOSCOPIC APPLICATOR ETHICON, Inc. GCJ Class II 2005-08-09
K052051 OMNI SPHINCTEROTOME Wilson-Cook Medical, Inc. KNS Class II 2005-08-05
K051814 JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET Jms North America Corp. FIE Class II 2005-08-04
K051610 HANS HERMANN LAPAROSCOPES AND ACCESSORIES Hans Hermann GmbH GCJ Class II 2005-07-29
K050808 CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 Cardio-Optics, Inc. LYK Class II 2005-07-28
K051581 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 Sanarus Medical, Inc. KNW Class II 2005-07-27
K051506 MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY Sterylab S.R.L. FCG Class II 2005-07-27
K051919 MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE Usgi Medical FED Class II 2005-07-26
K050136 REPROCESSED HOT BIOPSY FORCEPS Sterilmed, Inc. NLU Class II 2005-07-20
K042648 REPROCESSED COLD BIOPSY FORCEPS Sterilmed, Inc. NON Class I 2005-07-20
K050992 CONMED IRRIGATION NOZZLE Conmedcorp KPL Class II 2005-07-14
K050135 K-C HEMOSTATIC BIOPSY SYSTEM Bioengineering Consultants , Ltd. FCG Class II 2005-07-13
K051124 ZILVER 635 BILIARY STENT Cook, Inc. FGE Class II 2005-07-12
K051068 ZUTRON COLONOSCOPE STIFFENING DEVICE Zutron Medical FDF Class II 2005-07-11
K050502 SINGLE USE BALLOON DILATOR MAXPASSTM Olympus Winter & Ibe GmbH FGE Class II 2005-07-08
K051541 GF-UE160-AL5 ULTRASOUND ENDOSCOPE Olympus America, Inc. FDF Class II 2005-07-01
K050802 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. NAY Class II 2005-06-29
K051551 SMALL INTESTINAL VIDEOSCOPE SYSTEM Olympus Medical Systems Corporation KNT Class II 2005-06-28
K051059 AMSURE 100% SILICONE FOLEY CATHETER Amsino International, Inc. EZL Class II 2005-06-28
K050525 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. KDI Class II 2005-06-24
K043314 MANZI CLEANER SYSTEM Langford IC Systems, Inc. NVE Class II 2005-06-20
K051379 PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT Ev3 Corporation FGE Class II 2005-06-17
K051247 SONOTIP II ULTRASOUND NEEDLE SYSTEM Medi-Globe Corp. FCG Class II 2005-06-16
K050910 ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS Roei Medical Technologies, Ltd. FAS Class II 2005-06-16
K051504 SPYSCOPE ACCESS AND DELIVERY CATHETER Boston Scientific Corp FED Class II 2005-06-16
K051361 EASY CORE DETACHABLE BIOPSY SYSTEM Boston Scientific Corp KNW Class II 2005-06-16
K043031 SERIM DIALYSATE MONITOR TEST STRIP Serim Research Corp. NTZ Class II 2005-06-13
K050727 MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. KDI Class II 2005-06-13
K050603 OLPUR DIALYZER, MODEL HD 190 Nephros, Inc. KDI Class II 2005-06-09
K051187 REXEED SERIES DIALYZERS Asahi Kasei Medical Co., Ltd. KDI Class II 2005-06-08
K050008 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corp. EZD Class II 2005-06-03
K043574 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 Renal Solutions, Inc. FKT Class II 2005-06-03
K050795 IMBIBE BONE MARROW ASPIRATION NEEDLE Orthovita, Inc. KNW Class II 2005-06-03
K042431 PROCON2 Incontinent Control Devices, Inc. KNT Class II 2005-05-27
K033262 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) Gambro Renal Products FLD Class II 2005-05-27
K043342 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR Gambro Renal Products FJI Class II 2005-05-27
K050454 OMNITECH FULGURATING ELECTRODE Omnitech Systems, Inc. FAS Class II 2005-05-27
K050875 U-BALLOON DILATION CATHETER C.R. Bard, Inc. EZN Class II 2005-05-26
K043592 REPROCESSED ENDOSCOPIC TROCAR Sterilmed, Inc. NLM Class II 2005-05-23
K050534 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories FGE Class II 2005-05-20
K050650 NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 Cytyc Surgical Products GCJ Class II 2005-05-16
K051158 ENCOR 7 GAUGE Senorx, Inc. KNW Class II 2005-05-16
K050051 ARMAND ENDOSCOPE HOLDER KLS-Martin L.P. GCJ Class II 2005-05-16
K050503 SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 Olympus Medical Systems Corporation FCG Class II 2005-05-12
K043203 WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE Wilson-Cook Medical, Inc. KNT Class II 2005-05-11
K043044 ANTI-I.V. ENTERAL FEEDING SYSTEM Viasys Medsystems KNT Class II 2005-05-06
K050829 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM Conmed Integrated Systems (Cmis) GCJ Class II 2005-05-06
K050812 90XL INSTRUMENTATION SYSTEM Mesa Laboratories, Inc. FIZ Class II 2005-05-05
K050874 ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER Astra Tech, Inc. GBM Class II 2005-05-05
K050369 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc. NAY Class II 2005-04-29
K050578 COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE Cook Ireland, Ltd. KNS Class II 2005-04-22
K050777 PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 Conmedcorp FGE Class II 2005-04-22
K050725 PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3 Corporation FGE Class II 2005-04-20
K042018 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM Simply Clean Air & Water, Inc. FIP Class II 2005-04-15
K050483 EVADRI BLADDER CONTROL SYSTEMS Hollister, Inc. KPI Class II 2005-04-12
K043253 VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS Vanguard Medical Concepts, Inc. NLM Class II 2005-04-08
K050688 TEGRESS IMPLANT NEEDLE C.R. Bard, Inc. FBK Class II 2005-04-06
K043324 AIDA WITH DICOM AND HL7 INTERFACE KARL STORZ Endoscopy-America, Inc. FET Class II 2005-04-04
K050488 TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES Prosurg, Inc. FAS Class II 2005-04-01
K050294 COOK IRELAND SONNET POLYPECTOMY SNARE Cook Ireland, Ltd. FDI Class II 2005-03-31
K043418 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH Cook Urological, Inc. FED Class II 2005-03-31
K050639 LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM Lumenis, Inc. GCJ Class II 2005-03-31
K043594 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES Vanguard Medical Concepts, Inc. NLM Class II 2005-03-31
K043363 FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America FKX Class II 2005-03-31
K050698 MODIFICATION TO:ZILVER 518 BILIARY STENT Cook, Inc. FGE Class II 2005-03-30
K050163 HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE Henke Sass Wolf of America, Inc. GCJ Class II 2005-03-24
K042672 14F DUAL FLOATING DIALYSIS CATHETER/TRAY Cardio Med Supplies, Inc. MSD Class II 2005-03-23
K043344 DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM Dialysis Services, Inc. FIP Class II 2005-03-23
K050627 LIFESTENT TURBO BILIARY STENT SYSTEMS Edwards Lifesciences, LLC FGE Class II 2005-03-22
K042523 RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES Richard Wolf Medical Instruments Corp. FJL Class II 2005-03-18
K043436 NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 Nxstage Medical, Inc. FKR Class II 2005-03-17
K043021 STRYKER URETEROSCOPE Stryker Endoscopy FGB Class II 2005-03-16
K042901 ENDOMARK STERILE INDIA INK Pmt Corp. NBG Class II 2005-03-16
K043292 HEMOCATH Med-Conduit, Inc. MSD Class II 2005-03-16
K050091 TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) Direx Systems Corp. LNS Class II 2005-03-16
K040883 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products FEB Class II 2005-03-15
K043022 STRYKER FLEXIBLE CYSTONEPHROSCOPE Stryker Endoscopy FAJ Class II 2005-03-15
K050112 PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 Prime Pacific Health Innovations Corporation KPL Class II 2005-03-15
K050501 MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Vascular Devices FGE Class II 2005-03-14
K050232 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR Boston Scientific Corp PID Class II 2005-03-11
K043541 ENDOLINK TRUE MOVEMENT SYSTEM Novare Surgical Systems, Inc. GCJ Class II 2005-03-10
K042797 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Gambro Renal Products FIP Class II 2005-03-09

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