510(k) K153690 ยท KGN Wound Dressing With Animal-Derived Material(S)
PriMatrix Dermal Repair Scaffold
| Applicant | Tei Biosciences, Inc., Boston MD, US |
| Decision | Substantially Equivalent, Feb 22, 2016 |
| Received | Dec 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm. Open, Classified |
KGN | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1). Open, Classified |
KGN | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1). Open, Classified |
KGN | None listed |
| Jun 15, 2017 | TEI Biosciences PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's need Terminated |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.