510(k) Report

FDA applicant

W.L. Gore & Associates, Inc. Medical Products Div.

Flagstaff, AZ1 decision2008–20081 recall

FDA records 1 decision for W.L. Gore & Associates, Inc. Medical Products Div. (Flagstaff, AZ) in 2008: 1 510(k) clearance. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided W.L. Gore & Associates, Inc. Medical Products Div.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2008high 1 (2021) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — W.L. Gore & Associates, Inc. Medical Products Div. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like W.L. Gore & Associates, Inc. Medical…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081184Gore Viabil Bililary EndoprosthesisW.L. Gore & Associates, Inc. Medical Products Div. · 20081cites it

What has FDA decided for it lately?

  • K081184Gore Viabil Bililary EndoprosthesisW.L. Gore & Associates, Inc. Medical Products Div. · 20081 recall

The one decision as W.L. Gore & Associates, Inc. Medical Products Div. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081184GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts.…Apr 5, 2021Class II