K231614
- 510(k) number
- K231614
- Device name
- MiroTract Wound Matrix
- Applicant
- Reprise Biomedical, Inc. MN · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2023-12-13
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K231614.pdf
Official FDA record: K231614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.