FDA applicant
Cook Ireland, Ltd.
FDA records 37 decisions for Cook Ireland, Ltd. (Limerick, IE) from 2005 to 2026: 33 510(k) clearances, 1 De Novo grant and 3 original PMA approvals. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and FCG (Biopsy Needle). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 70 predicates, 16 of them its own earlier devices. 5 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Cook Ireland”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cook Ireland, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Cook Ireland, Ltd.’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.