FDA applicant
Cook Ob/Gyn
FDA records 43 decisions for Cook Ob/Gyn (Spencer, IN) from 1985 to 2006: 43 510(k) clearances. Most are in product codes MQF (Catheter, Assisted Reproduction) and HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 1 predicate, 1 of them its own earlier devices. 15 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cook Ob/Gyn’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cook Ob/Gyn since 2007.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Cook Ob/Gyn’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 “Cook”
FDA records each applicant name separately; these may or may not be the same firm.