FDA Product Code
FDA Product Code FGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 478 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102082 | EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 | Boston Scientific Corp | 2010-08-23 | Special | PDF ↗ |
| K101786 | ADVANIX DOUBLE PIGTAIL BILIARY STENT | Boston Scientific Corp | 2010-07-23 | Special | PDF ↗ |
| K101314 | ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM | Boston Scientific Corp | 2010-07-23 | Traditional | PDF ↗ |
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON | Wilson-Cook Medical, Inc. | 2010-07-19 | Traditional | PDF ↗ |
| K093003 | BONASTENT BILIARY | Endochoice, Inc. | 2010-03-24 | Traditional | PDF ↗ |
| K092352 | SCUBA BILIARY STENT SYSTEM | Invatec S.P.A. | 2010-03-16 | Traditional | PDF ↗ |
| K093947 | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC | Merit Medical Systems, Inc. | 2010-01-21 | Traditional | PDF ↗ |
| K093392 | MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS | Navilyst Medical, Inc. | 2009-12-31 | Abbreviated | PDF ↗ |
| K081996 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2009-09-15 | Traditional | PDF ↗ |
| K082093 | BULLSEYE BILIARY STENT SYSTEM | Squareone | 2009-07-29 | Traditional | PDF ↗ |
| K083374 | WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM | Boston Scientific Corp | 2009-04-22 | Traditional | PDF ↗ |
| K083627 | WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 | Boston Scientific Corporation | 2009-04-07 | Traditional | PDF ↗ |
| K090133 | CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS | Cook, Inc. | 2009-02-20 | Special | PDF ↗ |
| K081956 | MEDINOL X-SUIT NIR BILIARY METALLIC STENT | Medinol, Ltd. | 2009-01-09 | Traditional | PDF ↗ |
| K073667 | NITI-S BILIARY STENT | Taewoong Medical Co., Ltd. | 2008-11-19 | Abbreviated | PDF ↗ |
| K081733 | 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 | Boston Scientific Corp | 2008-10-27 | Traditional | PDF ↗ |
| K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | Abbott Vascular-Vascular Solutions | 2008-08-18 | Traditional | PDF ↗ |
| K080037 | MODIFICATION TO ZILVER 635 BILIARY STENT | Cook, Inc. | 2008-08-01 | Traditional | PDF ↗ |
| K081184 | GORE VIABIL BILILARY ENDOPROSTHESIS | W.L. Gore & Associates, Inc. Medical Products Div. | 2008-07-22 | Traditional | PDF ↗ |
| K063532 | BARD E LUMINEXX BILIARY STENT | Bard Peripheral Vascular, Inc. | 2008-05-30 | Traditional | PDF ↗ |
| K072720 | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM | Alveolus, Inc. | 2008-04-11 | Traditional | PDF ↗ |
| K072301 | 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 | Ev3, Inc. | 2008-03-18 | Traditional | PDF ↗ |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | Cordis Corp. | 2008-02-06 | Traditional | PDF ↗ |
| K071646 | SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 | Idev Technologies, Inc. | 2008-01-31 | Traditional | PDF ↗ |
| K073672 | SKATER BILIARY CATHETER | Angiotech | 2008-01-24 | Special | PDF ↗ |
| K063733 | RESOLVE BILIARY DRAINAGE CATHETER | Merit Medical Systems, Inc. | 2007-11-14 | Traditional | PDF ↗ |
| K062264 | COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM | Medtronic Vascular | 2007-11-08 | Traditional | PDF ↗ |
| K063481 | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM | Abbott Vascular, Inc. | 2007-09-14 | Traditional | PDF ↗ |
| K070610 | SKATER BILIARY CATHETER | Angiotech | 2007-06-21 | Traditional | PDF ↗ |
| K061231 | WELLFLEX BILIARY RX STENT SYSTEM | Boston Scientific Corp | 2006-09-01 | Traditional | PDF ↗ |
| K061566 | PRIMUS GPS BILIARY STENT SYSTEM | Ev3, Inc. | 2006-08-31 | Special | PDF ↗ |
| K060557 | SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 | Idev Technologies, Inc. | 2006-08-15 | Traditional | PDF ↗ |
| K060624 | MARATHON STENT WITH FUSION TECHNOLOGY | Cook Ireland, Ltd. | 2006-08-04 | Traditional | PDF ↗ |
| K060817 | OMNILINK. 018 BILIARY STENT SYSTEM | Guidant Endovascular Solutions, Inc. | 2006-06-15 | Traditional | PDF ↗ |
| K061235 | LIFESTENT TURBO BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2006-06-05 | Special | PDF ↗ |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Cordis Corp. | 2006-04-27 | Special | PDF ↗ |
| K053459 | OMNILINK .035 BILIARY STENT SYSTEM | Guidant Corporation | 2006-04-12 | Traditional | PDF ↗ |
| K060487 | LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2006-03-23 | Special | PDF ↗ |
| K060023 | ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER | AngioDynamics, Inc. | 2006-03-09 | Special | PDF ↗ |
| K060057 | PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM | Ev3, Inc. | 2006-03-08 | Special | PDF ↗ |
| K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM | Guidant Corporation | 2006-03-06 | Traditional | PDF ↗ |
| K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2005-12-21 | Special | PDF ↗ |
| K053245 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER | Uresil, LLC | 2005-12-20 | Special | PDF ↗ |
| K052539 | COOK FORMULA 418 BILIARY STENT SYSTEM | Cook, Inc. | 2005-12-09 | Special | PDF ↗ |
| K052114 | BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP | Bard Peripheral Vascular, Inc. | 2005-08-25 | Special | PDF ↗ |
| K052132 | MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2005-08-24 | Special | PDF ↗ |
| K051785 | FORMULA 418 BILIARY STENT | Cook, Inc. | 2005-08-23 | Traditional | PDF ↗ |
| K051124 | ZILVER 635 BILIARY STENT | Cook, Inc. | 2005-07-12 | Special | PDF ↗ |
| K050502 | SINGLE USE BALLOON DILATOR MAXPASSTM | Olympus Winter & Ibe GmbH | 2005-07-08 | Traditional | PDF ↗ |
| K051379 | PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT | Ev3 Corporation | 2005-06-17 | Special | PDF ↗ |
| K050534 | XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | Abbott Laboratories | 2005-05-20 | Special | PDF ↗ |
| K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | Conmedcorp | 2005-04-22 | Special | PDF ↗ |
| K050725 | PROTEGE GPS SELF-EXPANDING NITINOL STENT | Ev3 Corporation | 2005-04-20 | Special | PDF ↗ |
| K050698 | MODIFICATION TO:ZILVER 518 BILIARY STENT | Cook, Inc. | 2005-03-30 | Special | PDF ↗ |
| K050627 | LIFESTENT TURBO BILIARY STENT SYSTEMS | Edwards Lifesciences, LLC | 2005-03-22 | Special | PDF ↗ |
| K050501 | MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | Abbott Vascular Devices | 2005-03-14 | Special | PDF ↗ |
| K050103 | XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | Abbott Laboratories | 2005-02-16 | Special | PDF ↗ |
| K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK | Bioteque Corp. | 2005-02-14 | Traditional | PDF ↗ |
| K043481 | MODIFICATION TO: ZILVER 635 BILIARY STENT | Cook, Inc. | 2004-12-29 | Special | PDF ↗ |
| K042985 | LIFESTENT NT35 BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2004-12-23 | Special | PDF ↗ |
| K043243 | PRIMUS STENT AND DELIVERY SYSTEM | Ev3, Inc. | 2004-12-09 | Special | PDF ↗ |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2004-11-08 | Special | PDF ↗ |
| K042518 | ZILVER 518 BILIARY STENT | Cook, Inc. | 2004-10-01 | Special | PDF ↗ |
| K041962 | XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 | Abbott Laboratories | 2004-10-01 | Traditional | PDF ↗ |
| K042204 | MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT | Ev3, Inc. | 2004-08-23 | Special | PDF ↗ |
| K041796 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corporation | 2004-08-03 | Special | PDF ↗ |
| K041423 | VIABIL BILIARY ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2004-07-21 | Special | PDF ↗ |
| K041606 | EXTRACTOR RX RETRIEVAL BALLOON | Boston Scientific Corp | 2004-07-07 | Special | PDF ↗ |
| K040930 | ZILVER BILIARY STENT SYSTEM USW | Wilson-Cook Medical, Inc. | 2004-07-02 | Special | PDF ↗ |
| K040800 | WILOSN-COOK BILIARY DILATION BALLOON | Wilson-Cook Medical, Inc. | 2004-06-25 | Traditional | PDF ↗ |
| K041370 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2004-06-24 | Special | PDF ↗ |
| K040413 | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | Cordis Europa, N.V. | 2004-06-21 | Traditional | PDF ↗ |
| K041032 | MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2004-05-10 | Special | PDF ↗ |
| K040653 | PARAMOUNT MINI GPS BILIARY STENT SYSTEM | Ev3, Inc. | 2004-04-28 | Special | PDF ↗ |
| K040667 | XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 | Abbott Laboratories | 2004-04-07 | Special | PDF ↗ |
| K040027 | BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM | Boston Scientific | 2004-03-30 | Traditional | PDF ↗ |
| K040550 | LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2004-03-16 | Special | PDF ↗ |
| K040505 | ZILVER 635 BILIARY STENT | Cook, Inc. | 2004-03-16 | Special | PDF ↗ |
| K040151 | OASIS BILIARY STENT INTRODUCTION SYSTEM | Wilson-Cook Medical, Inc. | 2004-02-20 | Special | PDF ↗ |
| K033909 | WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM | Abbott Laboratories | 2004-02-17 | Traditional | PDF ↗ |
| K033497 | BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM | C.R. Bard, Inc. | 2004-02-04 | Special | PDF ↗ |
| K032436 | DURAMAX .018 BILIARY STENT SYSTEM | Avantec Vascular Corp. | 2004-02-04 | Traditional | PDF ↗ |
| K033834 | OMNILINK .018 BILIARY STENT SYSTEM | Guidant Corp. | 2004-01-02 | Special | PDF ↗ |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Cordis Corp. | 2003-12-22 | Special | PDF ↗ |
| K033348 | ZILVER 518 BILIARY STENT | Cook, Inc. | 2003-12-15 | Special | PDF ↗ |
| K033537 | SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 | Abbott Laboratories | 2003-12-10 | Special | PDF ↗ |
| K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM | Ev3, Inc. | 2003-11-21 | Special | PDF ↗ |
| K033134 | MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM | Ev3, Inc. | 2003-11-17 | Special | PDF ↗ |
| K011261 | STONE EXTRACTOR BALLOON CATHETER | Medi-Globe Corp. | 2003-11-17 | Traditional | PDF ↗ |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | Aomori Olympus Co., Ltd. | 2003-11-14 | Special | PDF ↗ |
| K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM | Guidant Corp. | 2003-11-10 | Special | PDF ↗ |
| K033212 | LIFESTENT SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2003-10-30 | Special | PDF ↗ |
| K032530 | MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM | Guidant Corporation | 2003-10-23 | Special | PDF ↗ |
| K032929 | MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 | Abbott Vascular, Inc. | 2003-10-22 | Special | PDF ↗ |
| K032580 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM | Ev3, Inc. | 2003-10-22 | Special | PDF ↗ |
| K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) | Medtronic Ave, Inc. | 2003-10-09 | Special | PDF ↗ |
| K032025 | SENTINOL NITINOL BILLARY STENT SYSTEM | Boston Scientific Corp | 2003-09-25 | Traditional | PDF ↗ |
| K031360 | GI SUPPLY BILIARY STENT | Gi Supply | 2003-09-24 | Traditional | PDF ↗ |
| K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2003-09-17 | Special | PDF ↗ |
| K032457 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2003-09-04 | Special | PDF ↗ |
Product code FGE · Class II · Gastroenterology, Urology. Data: openFDA.