FDA applicant
CooperSurgical, Inc.
FDA records 45 decisions for CooperSurgical, Inc. (Trumbull, CT) from 1991 to 2026: 42 510(k) clearances and 3 original PMA approvals. Most are in product codes HIH (Hysteroscope (And Accessories)) and LKF (Cannula, Manipulator/Injector, Uterine). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 9 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 CooperSurgical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like CooperSurgical, 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