510(k) K243897 · NEW Suture, Surgical, Absorbable, Polydioxanone
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Nov 12, 2025 |
| Received | Dec 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243897
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.