510(k) K251224
K251224 is an FDA 510(k) premarket notification submitted by Acera Surgical, Inc. for the device "Restrata Soft Tissue Reinforcement (STR)". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery), a Class II device regulated under 21 CFR 878.3300. Acera Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2025
- Date Received
- April 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.