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
97–120 of 476
Cleared Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877
Cordis Corp.
Gastroenterology & Urology · 27d
Cleared Mar 23, 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
K060487
Edwards Lifesciences, LLC
Gastroenterology & Urology · 27d
Cleared Mar 09, 2006
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
K060023
AngioDynamics, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 08, 2006
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
K060057
Ev3, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404
Edwards Lifesciences, LLC
Gastroenterology & Urology · 14d
Cleared Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539
Cook, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132
Edwards Lifesciences, LLC
Gastroenterology & Urology · 19d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785
Cook, Inc.
Gastroenterology & Urology · 53d
Cleared Jul 12, 2005
ZILVER 635 BILIARY STENT
K051124
Cook, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 08, 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
K050502
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 130d
Cleared May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534
Abbott Laboratories
Gastroenterology & Urology · 79d
Cleared Apr 22, 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
K050777
Conmedcorp
Gastroenterology & Urology · 25d
Cleared Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 22, 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
K050627
Edwards Lifesciences, LLC
Gastroenterology & Urology · 11d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103
Abbott Laboratories
Gastroenterology & Urology · 29d
Cleared Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481
Cook, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 23, 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985
Edwards Lifesciences, LLC
Gastroenterology & Urology · 55d
Cleared Dec 09, 2004
PRIMUS STENT AND DELIVERY SYSTEM
K043243
Ev3, Inc.
Gastroenterology & Urology · 16d
Cleared Nov 08, 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969
Cordis Corp.
Gastroenterology & Urology · 11d
Cleared Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
K041962
Abbott Laboratories
Gastroenterology & Urology · 72d
Cleared Oct 01, 2004
ZILVER 518 BILIARY STENT
K042518
Cook, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 23, 2004
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
K042204
Ev3, Inc.
Gastroenterology & Urology · 7d
Cleared Jul 21, 2004
VIABIL BILIARY ENDOPROSTHESIS
K041423
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 54d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606
Boston Scientific Corp
Gastroenterology & Urology · 22d