# K081184: Gore Viabil Bililary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: W.L. Gore & Associates, Inc. Medical Products Div.
- Decided: Jul 22, 2008 after 88 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023811 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041423: Viabil Biliary Endoprosthesis, W. L. Gore & Associates, Inc. (2004) Summary page 1.
- K023811: Modification to Viabahn Endoprosthesis, W. L. Gore & Associates, Inc. (2002) Summary page 1.

## Most influential descendants
- K170740: GORE VIABIL Short Wire Biliary Endoprosthesis (2017), 0 descendants of its own

## Recalls of this device
- Apr 5, 2021 · Class II · Z-1593-2021: The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.

## Indications for use
The GORE VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K081184
Methodology: https://510kreport.com/methodology