510(k) K252743 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Aug 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252743
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.