FDA applicant
ETHICON, Inc.
FDA records 213 decisions for ETHICON, Inc. (Somerville, NJ) from 1960 to 2026: 208 510(k) clearances and 5 original PMA approvals. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and FTL (Mesh, Surgical, Polymeric). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 109 predicates, 72 of them its own earlier devices. 122 recalls are linked to its devices.
FDA’s records also spell it “Ethicon, LLC”, “Ethicon GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided ETHICON, 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 2026
Class I Class II/III not classified
Planning a device like ETHICON, 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.