# K014215: Viabil Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 19, 2002 after 363 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Microvasive Modified Biliary Wallstent: named in the summary without a submission number
- (no number) Wallstent Biliary Transhepatic Endoprosthesis with Unistep Plus Delivery System: named in the summary without a submission number
- (no number) Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System: named in the summary without a submission number
- (no number) Cordis S.M.A.R.T. Nitinol Stent Endoscopic Biliary System: named in the summary without a submission number
- (no number) Wilson-Cook ST-2 Soehendra Tannenbaum Biliary Stent: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K014215
Methodology: https://510kreport.com/methodology