510(k) K223725
K223725 is an FDA 510(k) premarket notification submitted by Acera Surgical, Inc. for the device "Restrata® MiniMatrix". The FDA issued a decision of Substantially Equivalent on May 18, 2023. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Acera Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2023
- Date Received
- December 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.