FGE · Class II · 21 CFR 876.5010

FDA Product Code FGE: Stents, Drains And Dilators For The Biliary Ducts

FDA product code FGE covers stents, drains, and dilators for the biliary ducts.

These devices are used endoscopically or percutaneously to restore and maintain patency of the bile duct when obstructed by stones, strictures, or malignancy. Biliary stents are the mainstay of palliative treatment for malignant biliary obstruction and are also used in benign strictures following liver transplant or injury.

FGE devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and Cook, Inc..

478
Total
478
Cleared
127d
Avg days
1982
Since
478 devices
169–192 of 478
Cleared Jul 02, 2004
ZILVER BILIARY STENT SYSTEM USW
K040930
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 25, 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 24, 2004
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370
Orbus Medical Technologies
Gastroenterology & Urology · 31d
Cleared Jun 21, 2004
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K040413
Cordis Europa, N.V.
Gastroenterology & Urology · 124d
Cleared May 10, 2004
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K041032
Orbus Medical Technologies
Gastroenterology & Urology · 19d
Cleared Apr 28, 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653
Ev3, Inc.
Gastroenterology & Urology · 47d
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
K040667
Abbott Laboratories
Gastroenterology & Urology · 23d
Cleared Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 16, 2004
ZILVER 635 BILIARY STENT
K040505
Cook, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 16, 2004
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K040550
Orbus Medical Technologies
Gastroenterology & Urology · 14d
Cleared Feb 20, 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Feb 04, 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436
Avantec Vascular Corp.
Gastroenterology & Urology · 181d
Cleared Feb 04, 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
K033497
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834
Guidant Corp.
Gastroenterology & Urology · 23d
Cleared Dec 22, 2003
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K033394
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348
Cook, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
K033537
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314
Ev3, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261
Medi-Globe Corp.
Gastroenterology & Urology · 936d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393
Guidant Corp.
Gastroenterology & Urology · 18d
Cleared Oct 30, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS
K033212
Orbus Medical Technologies
Gastroenterology & Urology · 27d