FDA applicant
W. L. Gore & Associates, Inc.
FDA records 175 decisions for W. L. Gore & Associates, Inc. (Flagstaff, AZ) from 1980 to 2025: 163 510(k) clearances and 12 original PMA approvals. Most are in product codes FTL (Mesh, Surgical, Polymeric) and DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 106 predicates, 59 of them its own earlier devices. 19 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided W. L. Gore & Associates, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like W. L. Gore & Associates, Inc.’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