FDA applicant
Ethicon Endo-Surgery, Inc.
FDA records 186 decisions for Ethicon Endo-Surgery, Inc. (Cincinnati, OH) from 1992 to 2026: 185 510(k) clearances and 1 De Novo grant. Most are in product codes GDW (Staple, Implantable) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 229 predicates, 145 of them its own earlier devices. 67 recalls are linked to its devices, 18 Class I.
FDA’s records also spell it “Ethicon Endo-Surgery, LLC”, “Ethicon Endo-Surgery”, “Ethicon Endo Surgery, Inc.”, “Ethicon Endo Surgery, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ethicon Endo-Surgery, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Ethicon Endo-Surgery, 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 “Ethicon”
FDA records each applicant name separately; these may or may not be the same firm.