510(k) K212380 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 22, 2022 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2024 | Ethicon, Inc. PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. The Open, Classified |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.