FDA applicant
Ethicon Endo-Sugery, LLC
FDA records 6 decisions for Ethicon Endo-Sugery, LLC (Cincinnati, OH) from 2008 to 2011: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FZP (Clip, Implantable). Its devices cite 8 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ethicon Endo-Sugery, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2011
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Ethicon Endo-Sugery, LLC’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 “Ethicon”
FDA records each applicant name separately; these may or may not be the same firm.