Restrata® MiniMatrix
FDA 510(k) clearance K223725 · decided 2023-05-18
Clearance details
- K-number
- K223725
- Device name
- Restrata® MiniMatrix
- Applicant
- Acera Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-13
- Decision date
- 2023-05-18
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- QSZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| Restrata® (K193583) | Acera Surgical, Inc. | 2020-09-25 |
| Phoenix Wound Matrix (K173544) | Nanofiber Solutions, Inc. | 2018-03-02 |
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| SupraSDRM Biodegradable Matrix Wound Dressing (K170213) | Polymedics Innovations, GmbH | 2017-06-28 |
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Recalls involving this device
No recalls on record reference this clearance.