FDA applicant
W. L. Gore and Associates, Inc.
FDA records 4 decisions for W. L. Gore and Associates, Inc. (Flagstaff, AZ) from 2018 to 2022: 3 510(k) clearances and 1 original PMA approval. Most are in product codes MJN (Catheter, Intravascular Occluding, Temporary) and DQY (Catheter, Percutaneous). Its devices cite 4 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
How often FDA has decided W. L. Gore and Associates, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like W. L. Gore and 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