K253140
- 510(k) number
- K253140
- Device name
- CollOvine Wound Powder
- Applicant
- Ovigenex, LLC CA · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2026-02-10
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K253140.pdf
Official FDA record: K253140
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.