# K170740: GORE VIABIL Short Wire Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 8, 2017 after 59 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023811 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081184: Gore Viabil Bililary Endoprosthesis, W.L. Gore & Associates, Inc. Medical Products Div. (2008) Summary page 5.

## Recalls of this device
- Sep 3, 2026 · Class II · Z-0158-2027: The potential for the devices to be mislabeled with the incorrect length.
- May 22, 2026 · Class II · Z-2915-2026: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- May 22, 2026 · Class II · Z-2914-2026: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- Jan 19, 2024 · Class II · Z-1179-2024: Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device remova

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

Source page: https://510kreport.com/device/K170740
Methodology: https://510kreport.com/methodology