Absorbable Synthetic Wound Dressing
FDA product code QSZ · Unclassified · General, Plastic Surgery
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
21510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Polynovo Biomaterials Pty, Ltd. 5
- Acera Surgical, Inc. 3
- Sioxmed, LLC 3
- Polymedics Innovations, GmbH 2
- Biomet Merck GmbH 1
- Fidia Advanced Biopolymers Srl 1
- W. L. Gore & Associates, Inc. 1
- Engineered Tissue Solutions, LLC 1
- Nanofiber Solutions, LLC 1
- Beijing Kreate Medical Co., Ltd. 1
- Huizhou Foryou Medical Devices Co., Ltd. 1
- Anika Therapeutics, Inc. 1
510(k) clearances
| 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 |
| K223725 | Restrata® MiniMatrixQSZ · Traditional | Acera Surgical, Inc. | 05/18/2023SE |
| 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 |
| K173544 | Phoenix Wound MatrixQSZ · Traditional | Nanofiber Solutions, Inc. | 03/02/2018SE |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…QSZ · Special | Polynovo Biomaterials Pty, Ltd. | 08/11/2017SE |
| K170213 | SupraSDRM Biodegradable Matrix Wound DressingQSZ · Traditional | Polymedics Innovations, GmbH | 06/28/2017SE |
| K170300 | Restrata Wound MatrixQSZ · Traditional | Acera Surgical, Inc. | 04/26/2017SE |
| K161067 | Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen…QSZ · Traditional | Engineered Tissue Solutions, LLC | 09/15/2016SE |
| K142879 | BTM Wound DressingQSZ · Traditional | Polynovo Biomaterials Pty, Ltd. | 12/23/2015SE |
| K132397 | Gore Bio-A Wound MatrixQSZ · Traditional | W. L. Gore & Associates, Inc. | 05/07/2014SE |
| K090160 | Suprathel Wound and Burn DressingQSZ · Traditional | Polymedics Innovations, GmbH | 05/20/2009SE |
| K073251 | Hyalomatrix PaQSZ · Traditional | Fidia Advanced Biopolymers Srl | 12/14/2007SE |
| K031684 | Topkin Wound DressingQSZ · Traditional | Biomet Merck GmbH | 10/30/2003SE |