Product code QSZ
- Device name
- Absorbable Synthetic Wound Dressing
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-04-16 |
| K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | 2025-06-20 |
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 |
| K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024-07-05 |
| K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023-12-18 |
| K223725 | Restrata® MiniMatrix | Acera Surgical, Inc. | 2023-05-18 |
| K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022-11-18 |
| K221686 | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 |
| K193583 | Restrata® | Acera Surgical, Inc. | 2020-09-25 |
| K173544 | Phoenix Wound Matrix | Nanofiber Solutions, Inc. | 2018-03-02 |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 |
| K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations, GmbH | 2017-06-28 |
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017-04-26 |
| K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” | Engineered Tissue Solutions, LLC | 2016-09-15 |
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015-12-23 |
| K132397 | GORE BIO-A WOUND MATRIX | W. L. Gore & Associates, Inc. | 2014-05-07 |
| K090160 | SUPRATHEL WOUND AND BURN DRESSING | Polymedics Innovations, GmbH | 2009-05-20 |
| K073251 | HYALOMATRIX PA | Fidia Advanced Biopolymers Srl | 2007-12-14 |
| K031684 | TOPKIN WOUND DRESSING | Biomet Merck GmbH | 2003-10-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850021883041 | SiOxD Wound Matrix | Sioxmed, LLC | 2025-11-10 |
| 00850021883003 | SiOxD Wound Matrix | Sioxmed, LLC | 2025-11-10 |
| 00850047730336 | Foundation DRS Solo | Bionova Medical Inc. | 2025-09-17 |
| 00850047730329 | Foundation DRS Solo | Bionova Medical Inc. | 2025-09-17 |
| 00850047730312 | Foundation DRS Solo | Bionova Medical Inc. | 2025-09-17 |
| 00850047730305 | Foundation DRS Solo | Bionova Medical Inc. | 2025-09-17 |
| 10850021883000 | SiOxD Wound Matrix | Sioxmed, LLC | 2025-02-17 |
| 00812005030391 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2024-03-06 |
| 09349155001342 | NovoSorb MTX | POLYNOVO BIOMATERIALS PTY LIMITED | 2023-09-27 |
| 00812005030209 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2023-07-31 |
| 00812005030278 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2023-07-31 |
| 00850047730015 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730077 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730060 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730053 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730046 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730039 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730022 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 00850047730008 | Foundation DRS Solo | Bionova Medical Inc. | 2023-07-05 |
| 09349155001281 | NovoSorb MTX | POLYNOVO BIOMATERIALS PTY LIMITED | 2023-04-04 |
| 09349155001311 | NovoSorb MTX | POLYNOVO BIOMATERIALS PTY LIMITED | 2023-04-04 |
| 00812005030322 | MIRRASURG™ | ETS Wound Care LLC | 2023-02-01 |
| 00812005030315 | MIRRASURG™ | ETS Wound Care LLC | 2023-02-01 |
| 00812005030285 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2023-02-01 |
| 00812005030223 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2023-02-01 |
| 00812005030087 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2020-02-14 |
| B477MWM0404EA0 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2020-02-14 |
| 00812005030025 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2020-02-14 |
| B477MWM0202EA0 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2020-02-14 |
| B477MWM0106EA0 | MIRRAGEN® Advanced Wound Matrix | ETS Wound Care LLC | 2020-02-14 |