meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
2003-09-03

Clearances · page 44 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030662 PATHWAY ACCESS SHEATH CATHETER Vertelink Corporation EZN Class II 2003-09-03
K030652 MEDRO SPD Usfilter/Ionpure, Inc. FIP Class II 2003-09-03
K030633 MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT Medtronic Ave, Inc. FGE Class II 2003-09-02
K032544 VP-1000; MED CAM 100; VP-3000A; MED CAM 300 Mgb Endoskopische Gerate GmbH (Berlin) FET Class II 2003-09-02
K031758 ACMI M4 TELESCOPES Acmi Corporation FBP Class II 2003-09-02
K032545 ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 Mgb Endoskopische Gerate GmbH (Berlin) FET Class II 2003-09-02
K032360 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT Boston Scientific Corp FGE Class II 2003-08-27
K031748 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES Vitalcare Group, Inc. EZL Class II 2003-08-27
K022721 UROPOWER W.O.M. World of Medicine AG EXY Class II 2003-08-26
K031994 LINVATEC 300W XENON LIGHT SOURCE Linvatec Corp. GCT Class II 2003-08-21
K032283 DESIGNS FOR VISION FIBEROPTIC LIGHT Designs For Vision, Inc. GDB Class II 2003-08-20
K023902 SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE Usgi Medical, Inc. FED Class II 2003-08-20
K021560 MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS Ameriwater FIP Class II 2003-08-14
K031331 WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM Abbott Vascular, Inc. FGE Class II 2003-08-12
K032206 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION Ev3, Inc. FGE Class II 2003-08-08
K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. ODG Class II 2003-08-08
K032339 CARDIOVATIONS PORTABLE VIDEO SYSTEM ETHICON, Inc. GCJ Class II 2003-08-08
K023735 LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 Medsys, S.A. GCJ Class II 2003-08-07
K030119 NANMA ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. LKY Class II 2003-08-06
K030277 SOFT-CELL DUAL LUMEN CATHETERS C.R. Bard, Inc. MSD Class II 2003-08-06
K021362 LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) Organ Recovery Systems, Inc. KDN Class II 2003-07-31
K030268 NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS C.R. Bard, Inc. MPB Class II 2003-07-30
K031891 VIRTUOSAPH Terumo Cardiovascular Systems Corp. GCJ Class II 2003-07-29
K030170 REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 Opus Medical, Inc. OCW Class II 2003-07-28
K031256 XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE Olympus Opto-Electronics Co., Ltd. FDA Class II 2003-07-23
K030442 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. NFK Class II 2003-07-21
K031847 CARDIOVATIONS RETRACTOR ETHICON, Inc. GCJ Class II 2003-07-21
K031821 MODIFICATION TO COOK ZILVER BILIARY STENT Cook, Inc. FGE Class II 2003-07-18
K031956 MODIFICATION TO HERMES O.R. CONTROL CENTER Computer Motion, Inc. GCJ Class II 2003-07-17
K032092 OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE Olympus Optical Co., Ltd. FCL Class I 2003-07-16
K030960 ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE Acmi Corporation FAJ Class II 2003-07-16
K030456 VASC-ALERT Vasc-Alert, LLC KOC Class II 2003-07-11
K030841 COOK GASTRIC SIZING BALLOON CATHETER Cook, Inc. KNT Class II 2003-07-11
K031720 MODIFICATION TO HERMES O.R. CONTROL CENTER Computer Motion, Inc. GCJ Class II 2003-07-11
K030638 DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML Avantec Vascular Corp. FGE Class II 2003-07-09
K022558 NGT Medical Innovative Products KNT Class II 2003-07-08
K031777 MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2003-07-07
K030470 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. FII Class II 2003-07-07
K030919 SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES Medisiss NLR Class II 2003-07-03
K024303 EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM Edwards Lifesciences, LLC FGE Class II 2003-07-03
K031033 GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2003-07-01
K031141 ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE Asap Endoscopic Products GmbH FAJ Class II 2003-06-30
K031382 MODIFICATION TO HERMES O.R. CONTROL CENTER Computer Motion, Inc. GCJ Class II 2003-06-30
K031538 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT Boston Scientific Corp KNT Class II 2003-06-27
K031026 ETI BIPOLAR HEMOSTATIC PROBE Endo-Therapeutics, Inc. KNS Class II 2003-06-27
K023011 OSMONICS SOLUTION DELIVERY SYSTEM Osmonics Medical Systems FIN Class II 2003-06-26
K031773 ENDO GATOR SYSTEM Byrne Medical, Inc. OCX Class II 2003-06-24
K030578 BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM Computer Motion, Inc. NAY Class II 2003-06-24
K031029 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM Arthrocare Corp. FAS Class II 2003-06-19
K030174 GENICON LAPAROSCOPES Genicon, LC GCJ Class II 2003-06-19
K030099 BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 Baxter Healthcare Corp KDI Class II 2003-06-17
K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER Rusch Intl. FGE Class II 2003-06-17
K031409 URINARY CATHETERS Promedic, Inc. GBM Class II 2003-06-17
K030020 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER C.R. Bard, Inc. MSD Class II 2003-06-16
K031197 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2003-06-16
K024010 DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER The Kendall Company Div. of Tyco Healthcare Group EZL Class II 2003-06-11
K030765 HOBBS MISTIFIER SPRAY CATHETER Hobbs Medical, Inc. OCX Class II 2003-06-09
K030718 SCB COMPUTER MOTION INTERFACE CONTROLLER Computer Motion, Inc. GCJ Class II 2003-06-05
K022393 MERDOC SYSTEM Stryker Endoscopy GCJ Class II 2003-06-05
K031527 MODIFICATION TO CAVERMAP SURGICAL AID Blue Torch Medical Technologies FGM Class I 2003-06-05
K031098 3-CCD DIGITAL CAMERA SYSTEM Linvatec Corp. GCJ Class II 2003-06-04
K030824 LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 Hakko Medical Co., Ltd. GCJ Class II 2003-06-04
K030913 NANMA VACUUM PUMP Nanma Mfg Co., Ltd. LKY Class II 2003-06-03
K030684 SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH Acmi Corporation OCU Class II 2003-06-03
K030813 PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND Primary Care Solutions, Inc. EZL Class II 2003-05-30
K030839 MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) Medtronic Ave, Inc. FGE Class II 2003-05-30
K031378 FRESENIUS ULTRAFLUX HEMODIALYZER Fresenius Medical Care North America KDI Class II 2003-05-30
K022448 WATER PURIFICATION SYSTEM Purity Water Company of San Antonio, Inc. FIP Class II 2003-05-28
K030642 DEFLECTING URETERAL ACCESS SHEATH Applied Medical Resources Corp. FED Class II 2003-05-23
K030039 PATHWAY STM-10 PELVIC FLOOR STIMULATOR The Prometheus Group KPI Class II 2003-05-23
K031344 RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE Ranfac, Corp. KNW Class II 2003-05-23
K030956 NAVIGATOR URETERAL ACCESS SHEATH SET Boston Scientific Corp FED Class II 2003-05-23
K030664 AMSURE FOLEY INSERTION TRAY Amsino International, Inc. FCM Class II 2003-05-23
K030592 GAMBRO POLYFLUX, MODEL 140H, 170H, 210H Gambro Renal Care Products KDI Class II 2003-05-23
K031262 ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 Ndo Surgical, Inc. ODE Class II 2003-05-23
K030712 AMSURE URETHRAL CATHETERIZATION TRAY Amsino International, Inc. FCM Class II 2003-05-23
K031292 MODIFICATION TO FOSSA URETERAL STONE SWEEPER Fossa Medical, Inc. FAD Class II 2003-05-22
K031379 DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 Smith & Nephew, Inc. GCJ Class II 2003-05-22
K031001 ACMI VISTA CTR BIPOLAR LOOP ELECTRODE Acmi Corporation FAS Class II 2003-05-21
K030497 FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES Fresenius Medical Care KPO Class II 2003-05-20
K030502 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 Medcomp MSD Class II 2003-05-20
K030512 GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM Guidant Corp. GCJ Class II 2003-05-14
K030209 MAHURKAR OPLUS CATHETER, MODEL 13.5 FR The Kendall Company MPB Class II 2003-05-13
K030443 MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST Nastech Pharmaceutical Company, Inc. KNW Class II 2003-05-09
K031347 ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 Olympus Optical Co., Ltd. ODG Class II 2003-05-09
K022662 DIATEK CANNON-CATHETER, MODEL CC5500 Arrow Intl., Inc. MSD Class II 2003-05-09
K023615 GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR Gambro Renal Products MSF Class II 2003-05-06
K031186 LUMINEXX ENDOSCOPIC BILIARY STENT C.R. Bard, Inc. FGE Class II 2003-05-06
K030346 TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Fmd, LLC LNS Class II 2003-05-02
K023847 HEMO-STREAM HEMODIALYSIS CATHETER SET Rex Medical MSD Class II 2003-04-30
K030451 CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE Carbon Medical Technologies, Inc. FBK Class II 2003-04-30
K023905 ATHENA PELVIC MUSCLE TRAINER Athena Feminine Technologies, Inc. KPI Class II 2003-04-30
K030975 EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 Baxter Healthcare Corp KDI Class II 2003-04-25
K030983 TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY Deltec, Inc. MSD Class II 2003-04-25
K030974 EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 Baxter Healthcare Corp KDI Class II 2003-04-25
K021939 VITALCARE FOLEY CATHETER Vitalcare, Inc. EZL Class II 2003-04-22
K021938 VITALCARE URETHRAL CATHETER Vitalcare, Inc. GBM Class II 2003-04-22
K030855 MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT Boston Scientific Corp KNT Class II 2003-04-17
K023234 ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. ODE Class II 2003-04-17
K021672 PANCREATIC DRAINAGE TUBE Aomori Olympus Co., Ltd. FGE Class II 2003-04-16

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