510(k) K253572 · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253572
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.