FDA applicant
Codman & Shurtleff, Inc.
FDA records 152 decisions for Codman & Shurtleff, Inc. (Raynham, MA) from 1976 to 2020: 152 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GWM (Device, Monitoring, Intracranial Pressure). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 110 predicates, 44 of them its own earlier devices. 27 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Codman & Shurtleff, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
3in 2025
Class I Class II/III not classified
Planning a device like Codman & Shurtleff, 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 “Codman”
FDA records each applicant name separately; these may or may not be the same firm.