FDA applicant
Cook Urological, Inc.
FDA records 104 decisions for Cook Urological, Inc. (Spencer, IN) from 1986 to 2011: 104 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and FAD (Stent, Ureteral). Its devices cite 41 predicates, 6 of them its own earlier devices. 39 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 Urological, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Cook Urological, 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 “Cook”
FDA records each applicant name separately; these may or may not be the same firm.