510(k) K233991
K233991 is an FDA 510(k) premarket notification submitted by Elutia, Inc. for the device "CanGaroo RM Antibacterial Envelope". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2024
- Date Received
- December 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type