FDA applicant
Winn Hirsch & Assoc.
FDA records 11 decisions for Winn Hirsch & Assoc. (Mchenry, IL) from 1976 to 1988: 11 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and EFQ (Gauze/Sponge, Internal). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Winn Hirsch & Assoc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Winn Hirsch & Assoc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Winn Hirsch & Assoc.’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