Restrata® MiniMatrix
FDA 510(k) K223725 · Acera Surgical, Inc.
510(k) numberK223725
Submission
- Device name
- Restrata® MiniMatrix
- Applicant
- Acera Surgical, Inc.
St. Louis, MO, US - Received
- December 13, 2022
- Decision date
- May 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSZ – Absorbable Synthetic Wound Dressing
- Device class
- Unclassified
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Other 510(k)s with product code QSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261311 | HyalomatrixQSZ · Traditional | Anika Therapeutics, Inc. | 09/02/2026SE |
| K254256 | LUOFUCON® Wound MatrixQSZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 08/18/2026SE |
| K260020 | Redermo Wound MatrixQSZ · Traditional | Beijing Kreate Medical Co., Ltd. | 04/16/2026SE |
| K251567 | NovoSorb BTMQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 06/20/2025SE |
| K242149 | NovoSorb® MTXQSZ · Traditional | Polynovo Biomaterials Pty, Ltd. | 03/05/2025SE |
| K241660 | SiOxD® Wound MatrixQSZ · Special | Sioxmed, LLC | 07/05/2024SE |
| K232847 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 12/18/2023SE |
| K222189 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 11/18/2022SE |
| K221686 | NovoSorb MatrixQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 09/15/2022SE |
| K193583 | Restrata®QSZ · Special | Acera Surgical, Inc. | 09/25/2020SE |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR)OXF · Traditional | 06/20/2025SE |
| K193583 | Restrata®QSZ · Special | 09/25/2020SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | 11/27/2017SE |
| K170300 | Restrata Wound MatrixQSZ · Traditional | 04/26/2017SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | 03/16/2016SE |
Questions and answers
When was Restrata® MiniMatrix cleared by the FDA?
Restrata® MiniMatrix (K223725) received a 510(k) decision of Substantially Equivalent on May 18, 2023, 156 days after the submission was received.
What is the product code of K223725?
The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.