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..

476
Total
476
Cleared
127d
Avg days
1982
Since
476 devices
145–168 of 476
Cleared Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
K024303
Edwards Lifesciences, LLC
Gastroenterology & Urology · 191d
Cleared Jun 17, 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666
Rusch Intl.
Gastroenterology & Urology · 229d
Cleared Jun 16, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared May 06, 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645
Boston Scientific Corp
Gastroenterology & Urology · 25d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107
Boston Scientific Corp
Gastroenterology & Urology · 67d
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409
Cordis Corp.
Gastroenterology & Urology · 31d
Cleared Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994
C.R. Bard, Inc.
Gastroenterology & Urology · 198d
Cleared Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 363d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
K021824
Guidant Corp.
Gastroenterology & Urology · 28d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K021345
Cordis Corp.
Gastroenterology & Urology · 60d
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 Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052
Cordis Corp.
Gastroenterology & Urology · 34d
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