QSZ · Absorbable Synthetic Wound Dressing
· Class U
Overview
| Product Code | QSZ |
|---|---|
| Device Name | Absorbable Synthetic Wound Dressing |
| Device Class | Class U |
| Review Panel |
Identification
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | Apr 16, 2026 | SESE |
| K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | Jun 20, 2025 | SESE |
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | Mar 5, 2025 | SESE |
| K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | Jul 5, 2024 | SESE |
| K232847 | SiOxD Wound Matrix | Sioxmed, LLC | Dec 18, 2023 | SESE |
| K223725 | Restrata® MiniMatrix | Acera Surgical, Inc. | May 18, 2023 | SESE |
| K222189 | SiOxD Wound Matrix | Sioxmed, LLC | Nov 18, 2022 | SESE |
| K221686 | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | Sep 15, 2022 | SESE |
| K193583 | Restrata® | Acera Surgical, Inc. | Sep 25, 2020 | SESE |
| K173544 | Phoenix Wound Matrix | Nanofiber Solutions, Inc. | Mar 2, 2018 | SESE |
| 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. | Aug 11, 2017 | SESE |
| K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations, GmbH | Jun 28, 2017 | SESE |
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | Apr 26, 2017 | SESE |
| K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” | Engineered Tissue Solutions, LLC | Sep 15, 2016 | SESE |
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | Dec 23, 2015 | SESE |
| K132397 | GORE BIO-A WOUND MATRIX | W. L. Gore & Associates, Inc. | May 7, 2014 | SESE |
| K090160 | SUPRATHEL WOUND AND BURN DRESSING | Polymedics Innovations, GmbH | May 20, 2009 | SESE |
| K073251 | HYALOMATRIX PA | Fidia Advanced Biopolymers Srl | Dec 14, 2007 | SESE |
| K031684 | TOPKIN WOUND DRESSING | Biomet Merck GmbH | Oct 30, 2003 | SESE |
Top Applicants
- Polynovo Biomaterials Pty, Ltd. — 5 clearances
- Acera Surgical, Inc. — 3 clearances
- Sioxmed, LLC — 3 clearances
- Polymedics Innovations, GmbH — 2 clearances
- Beijing Kreate Medical Co., Ltd. — 1 clearance
