510(k) K151200 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Aug 13, 2015 |
| Received | May 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2022 | Ethicon, Inc. STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Product No.: SXMD1B405-12 Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.