510(k) K192580 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 18, 2019 |
| Received | Sep 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Ethicon, Inc. STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM-
Indicated for use in soft tissue approximation Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.