K241904
- 510(k) number
- K241904
- Device name
- DermiSphere Dermal Template
- Applicant
- Fesariustherapeutics, Inc. NY · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2025-01-06
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241904.pdf
Official FDA record: K241904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.