K233991
- 510(k) number
- K233991
- Device name
- CanGaroo RM Antibacterial Envelope
- Applicant
- Elutia, Inc. GA · US
- Product code
- FTM — Mesh, Surgical
- Decision date
- 2024-06-14
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233991.pdf
Official FDA record: K233991
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.