510(k) K083898 ยท FTM Mesh, Surgical
SURGIMEND
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Dec 29, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval, Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated. Open, Classified |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.