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
169–192 of 476
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 12, 2003
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
K031331
Abbott Vascular, Inc.
Gastroenterology & Urology · 106d
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
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 21, 2003
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
K010714
Medi-Globe Corp.
Gastroenterology & Urology · 683d
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