# K041423: Viabil Biliary Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jul 21, 2004 after 54 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VIABIL™ Biliary Endoprosthesis: named in the summary without a submission number

## Most influential descendants
- K081184: Gore Viabil Bililary Endoprosthesis (2008), 1 descendant of its own
- K170740: GORE VIABIL Short Wire Biliary Endoprosthesis (2017), 0 descendants of its own

## Indications for use
The VIABIL M Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.

Source page: https://510kreport.com/device/K041423
Methodology: https://510kreport.com/methodology