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 C.R. Bard, Inc..

474
Total
474
Cleared
127d
Avg days
1982
Since
474 devices
97–120 of 474
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 Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052
Cordis Corp.
Gastroenterology & Urology · 34d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909
Boston Scientific Corp
Gastroenterology & Urology · 162d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752
Boston Scientific Corp
Gastroenterology & Urology · 91d
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 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087
Cordis Corp.
Gastroenterology & Urology · 29d
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
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 05, 2001
BARD LUMINEXX BILIARY STENT
K003793
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258
Cordis Corp.
Gastroenterology & Urology · 70d
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308
Boston Scientific Corp
Gastroenterology & Urology · 108d
Cleared Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303
Boston Scientific Corp
Gastroenterology & Urology · 171d
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
K994156
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392
C.R. Bard, Inc.
Gastroenterology & Urology · 90d