meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
2009-03-09

Clearances · page 35 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090419 SILS STITCH ENDOSCOPIC SUTURING DEVICE Covidien Lp, Formerly Registered AS United States OCW Class II 2009-03-09
K083218 TC ENDO PORT Transcardiac Therapeutics, Inc. GCJ Class II 2009-03-06
K083776 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S Corpak Medsystems FPD Class II 2009-03-05
K083791 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S Corpak Medsystems FPD Class II 2009-03-04
K083788 ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR Endooptiks, Inc. EYB Class II 2009-03-03
K083786 CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB Corpak Medsystems FPD Class II 2009-02-20
K083778 XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 Baxter Healthcare Corporation KDI Class II 2009-02-20
K090133 CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS Cook, Inc. FGE Class II 2009-02-20
K083556 MODIFICATION TO AUTO-BAND LIGATOR Scandimed International MND Class II 2009-02-19
K081137 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 Intuitive Surgical, Inc. NAY Class II 2009-02-18
K090275 GELPORT SINGLE INCISION ACCESS SYSTEM Applied Medical Resources Corp. GCJ Class II 2009-02-18
K082988 MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT Medivators Reprocessing Systems FEB Class II 2009-02-13
K083180 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM Avantis Medical Systems, Inc. FDF Class II 2009-02-12
K090102 NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS C.R. Bard, Inc. MPB Class II 2009-02-12
K090101 EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS C.R. Bard, Inc. MSD Class II 2009-02-10
K090255 BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. FJK Class II 2009-02-10
K082995 SMART DILATOR Safestitch Medical KNQ Class II 2009-02-06
K083330 ECHOTIP ULTRA ULTRASOUND NEEDLE Cook Endoscopy FCG Class II 2009-02-06
K083684 ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX Manufacturing & Research, Inc. KNT Class II 2009-02-05
K083153 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 Hollister, Inc. KNT Class II 2009-02-04
K090170 SPYSCOPE ACCESS AND DELIVERY CATHETER Boston Scientific Corp ODF Class II 2009-02-04
K082400 DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS Culligan Soft Water Service Co. FIP Class II 2009-02-03
K082710 SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET Neochild, LLC KNT Class II 2009-01-23
K083453 COSTORSOL Preservation Solutions, Inc. KDN Class II 2009-01-21
K082882 A.V. FISTULA BLUNT NEEDLE SET Jms North America Corp. FIE Class II 2009-01-21
K083194 VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 Terumo Cardiovascular Systems Corp. GCJ Class II 2009-01-16
K080964 FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America KDI Class II 2009-01-14
K083155 HD CAMERA HEAD OTV-S7PROH-HD-L08E Olympus Medical Systems Corporation FET Class II 2009-01-13
K082863 DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) Dynarex Corporation KNT Class II 2009-01-09
K081956 MEDINOL X-SUIT NIR BILIARY METALLIC STENT Medinol, Ltd. FGE Class II 2009-01-09
K082291 A-LAP SET (A-LAP, EZAXESS, TROCAR) Ezsurgical GCJ Class II 2009-01-02
K083542 FRESENIUS STERILE STAY SAFE CAP Fresenius Medical Care North America KDJ Class II 2008-12-29
K083210 CORFLO ANTI IV ENTERAL FEEDING TUBE Corpak Medsystems FPD Class II 2008-12-29
K083049 TORNADO ROTATABEL SNARE AND POLYP CATCHER Horizons Intl. Corp. FDI Class II 2008-12-23
K083638 FIXATION TROCARS Applied Medical Resources Corp. GCJ Class II 2008-12-23
K082813 STRYKER LED LIGHTSOURCE Stryker Corp. FCW Class II 2008-12-19
K082114 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 Apollo Endosurgery, Inc. KNS Class II 2008-12-19
K081207 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE Intuitive Surgical, Inc. NAY Class II 2008-12-19
K082758 PRISMAFLO II Stihler Electronic GmbH KOC Class II 2008-12-19
K082925 XENON-100 SCB LIGHT SOURCE, MODEL 20132620 KARL STORZ Endoscopy-America, Inc. GCT Class II 2008-12-18
K082701 URONIRS, MODEL 2000 Urodynamix Technologies, Ltd. FEN Class II 2008-12-18
K082233 VIKY Endocontrol GCJ Class II 2008-12-18
K083211 AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM Surgiquest, Inc. GCJ Class II 2008-12-15
K072831 FROG Newby-Coombs, LLC FPD Class II 2008-12-12
K081990 LUBRICANO STERILE GEL Farco Pharma GmbH FHX Class II 2008-12-05
K081739 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT Boston Scientific Corp KNT Class II 2008-12-03
K080650 OMNI-DL SYSTEM Transvivo, Inc. KDI Class II 2008-11-26
K082654 ENTERAL ONLY EXTENSION SET Respironics, Inc. KNT Class II 2008-11-25
K081313 SH14 HEMOCONCENTRATOR Sorin Group Italia S.R.L. KDI Class II 2008-11-19
K073667 NITI-S BILIARY STENT Taewoong Medical Co., Ltd. FGE Class II 2008-11-19
K082322 AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS Covidien GCJ Class II 2008-11-14
K082392 EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products FEB Class II 2008-11-13
K082803 COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 Percutaneous Systems, Inc. FFL Class II 2008-11-13
K082619 SILS PORT, MODELS SILSPT5, SILSPT12 Covidien Lp, Formerly Registered AS United States GCJ Class II 2008-11-07
K081725 ENTERAL PUMP SET, MODEL 20-1010 Viasys Medsystems KNT Class II 2008-11-07
K082056 ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 Life-Tech, Inc. FFX Class II 2008-11-07
K080613 CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 Minimally Invasive Devices, LLC OCT Class II 2008-11-06
K081456 OLYMPUS CHF TYPE V Olympus Medical Systems Corporation FBN Class II 2008-11-06
K082241 THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 Dale Medical Products, Inc. KNT Class II 2008-10-30
K082414 OPTIFLUX F250NR, MODEL 0500325E Fresenius Medical Care North America KDI Class II 2008-10-28
K081733 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 Boston Scientific Corp FGE Class II 2008-10-27
K082464 PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 Medtronic, Inc. KNS Class II 2008-10-27
K082536 COOK WIRE GUIDES Cook Urological, Inc. OCY Class II 2008-10-27
K082919 UC-CARE POSITIONING SYSTEM Uc-Care Medical Systems, Ltd. EZL Class II 2008-10-27
K082831 AMSELF CLOSED CATHETERIZATION SYSTEM Amsino International, Inc. FCM Class II 2008-10-23
K082576 XCHF-T160 VIDEOSCOPE Olympus Medical Systems Corporation FBN Class II 2008-10-21
K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 2008-10-20
K082681 VACORA VACUUM ASSISTED BIOPSY SYSTEM C.R. Bard, Inc. KNW Class II 2008-10-15
K080919 NXSTAGE PUREFLOW SL Nxstage Medical, Inc. FKR Class II 2008-10-15
K082046 KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO KARL STORZ Endoscopy-America, Inc. FBO Class II 2008-10-10
K081997 PERFADEX WITH THAM Vitrolife Sweden AB MSB Class II 2008-10-09
K082815 WELL LEAD SILICONE AND LATEX FOLEY CATHETERS Well Lead Medical Instruments EZL Class II 2008-10-08
K082515 ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX Asahi Kasei Medical Co., Ltd. KDI Class II 2008-10-03
K081995 STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) Stryker Endoscopy GCJ Class II 2008-10-02
K082238 NEOMED POLYURETHANE FEEDING TUBE Neomed, Inc. FPD Class II 2008-10-01
K082319 INJEKT FILIFORM INJECTION NEEDLE Cook Urological, Inc. FBK Class II 2008-09-25
K082659 MODIFIED ENDO STICH Covidien Lp, Formerly Registered AS United States OCW Class II 2008-09-19
K081480 KEGEL8 PELVIC EXERCISER, MODEL OPH 400 Ne Services , Ltd. KPI Class II 2008-09-12
K082156 ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 Teleflex Medical GCJ Class II 2008-09-10
K081708 TAXI ENDOSCOPIC GUIDEWIRE Lake Region Mfg., Inc. OCY Class II 2008-08-26
K081853 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM Apollo Endosurgery, Inc. OCW Class II 2008-08-18
K072708 ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM Abbott Vascular-Vascular Solutions FGE Class II 2008-08-18
K080809 IEC MEDSIGHT AND MEDBRIGHT Innovative Endoscopy Components, LLC FET Class II 2008-08-11
K080432 MAPERSOL Preservation Solutions, Inc. KDN Class II 2008-08-08
K072293 FOSSA URETERAL OPEN STENTS Fossa Medical, Inc. FAD Class II 2008-08-06
K073112 DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 Intuitive Surgical, Inc. NVE Class II 2008-08-01
K080037 MODIFICATION TO ZILVER 635 BILIARY STENT Cook, Inc. FGE Class II 2008-08-01
K080780 ANCHORAGE SCOPE, MODEL 000003 Epitek, Inc. FBO Class II 2008-07-30
K081184 GORE VIABIL BILILARY ENDOPROSTHESIS W.L. Gore & Associates, Inc. Medical Products Div. FGE Class II 2008-07-22
K081323 BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 B-K Medical Aps FCG Class II 2008-07-22
K080807 BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. FJK Class II 2008-07-18
K081288 ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. Bard, Inc. PNG Class II 2008-07-18
K080067 ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Iscience Interventional MPA Class II 2008-07-18
K080878 MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) Medical Technologies of Georgia, Inc. KOD Class II 2008-07-17
K081043 LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT Nxstage Medical, Inc. KOC Class II 2008-07-07
K073693 COSTORSOL Preservation Solutions, Inc. KDN Class II 2008-07-03
K080679 MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 Viasys Medsystems KNT Class II 2008-06-27
K073644 ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES Endogastric Solutions, Inc. OCW Class II 2008-06-27
K081585 ENDOSCOPY VIDEO CAMERA SYSTEM Vision Systems Group, A Division of Viking Systems FET Class II 2008-06-20
K081477 LUXTEC MLX LIGHT SOURCE Integra Luxtec, Inc. FCW Class II 2008-06-18

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