510(k) K162965 ยท FTM Mesh, Surgical
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Oct 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm. Open, Classified |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.