510(k) K192144 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 25, 2020 |
| Received | Aug 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | ETHICON, LLC STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11. Open, Classified |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.