K251845
- 510(k) number
- K251845
- Device name
- Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
- Applicant
- Kerecis Limited IS
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2025-07-16
- Date received
- 2025-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251845.pdf
Official FDA record: K251845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.