510(k) K152721 ยท KGN Wound Dressing With Animal-Derived Material(S)
Cytal Wound Matrix
| Applicant | Acell, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 8, 2015 |
| Received | Sep 21, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Open, Classified |
KGN | None listed |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Open, Classified |
KGN | None listed |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Open, Classified |
KGN | None listed |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Open, Classified |
KGN | None listed |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Open, Classified |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.