510(k) K171357 ยท OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
SurgiMend PRS Meshed, Revize-X
| Applicant | Integra Lifesciences Corporation (Owner of Tei Biosciences), Boston MA, US |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | May 9, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 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.