FDA applicant
Wilson-Cook Medical, Inc.
FDA records 127 decisions for Wilson-Cook Medical, Inc. (Winston-Salem, NC) from 1985 to 2026: 126 510(k) clearances and 1 De Novo grant. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and KNT (Tubes, Gastrointestinal (And Accessories)). Since 2016 its 510(k)s took a median of 155 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 50 of them its own earlier devices. 50 recalls are linked to its devices.
FDA’s records also spell it “Wilson Cook Medical”, “Wilson-Cook Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wilson-Cook Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Wilson-Cook Medical, 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) ReportOther applicant names beginning “Wilson-Cook”
FDA records each applicant name separately; these may or may not be the same firm.