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
193–216 of 476
Cleared May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
K020788
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K013737
Telemed Systems, Inc.
Gastroenterology & Urology · 108d
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052
Cordis Corp.
Gastroenterology & Urology · 34d
Cleared Jan 18, 2002
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
K010549
Medi-Globe Corp.
Gastroenterology & Urology · 326d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184
Guidant Corp.
Gastroenterology & Urology · 29d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909
Boston Scientific Corp
Gastroenterology & Urology · 162d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601
Cook, Inc.
Gastroenterology & Urology · 261d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752
Boston Scientific Corp
Gastroenterology & Urology · 91d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Sep 07, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K012590
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684
Guidant Corp.
Gastroenterology & Urology · 35d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445
Cordis Corp.
Gastroenterology & Urology · 30d