510(k) K170740 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
GORE VIABIL Short Wire Biliary Endoprosthesis
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Unknown, May 8, 2017 |
| Received | Mar 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2026 | W L Gore & Associates, Inc. Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;
Model/Catalog Number: VSWVH0808 and VSWVN1006
Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-ex Open, Classified |
FGE | None listed |
| Aug 7, 2026 | W L Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. Open, Classified |
FGE | None listed |
| Aug 7, 2026 | W L Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. Open, Classified |
FGE | None listed |
| Feb 22, 2024 | W.L. Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as
(1) Catalog Number VSWVH1008, 10 mm x 8 cm;
with holes; and
(2) Catalog Number VSWVN1008, 10 mm x 8 cm;
no holes Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.