510(k) K253852 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Dec 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253852
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.