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 Wilson-Cook Medical, Inc..

476
Total
476
Cleared
127d
Avg days
1982
Since
476 devices
121–144 of 476
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 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 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
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
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393
Guidant Corp.
Gastroenterology & Urology · 18d
Cleared Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580
Ev3, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 17, 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137
Cordis Corp.
Gastroenterology & Urology · 68d
Cleared Sep 04, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032457
Cordis Corp.
Gastroenterology & Urology · 24d
Cleared Aug 27, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
K032360
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Aug 08, 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
K032206
Ev3, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 18, 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
K031821
Cook, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777
Cordis Corp.
Gastroenterology & Urology · 27d