

# QSZ · Absorbable Synthetic Wound Dressing

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/QSZ

## Overview

- **Product Code:** QSZ
- **Device Name:** Absorbable Synthetic Wound Dressing
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## 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](/device/K260020.md) | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | Apr 16, 2026 | SESE |
| [K251567](/device/K251567.md) | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | Jun 20, 2025 | SESE |
| [K242149](/device/K242149.md) | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | Mar 5, 2025 | SESE |
| [K241660](/device/K241660.md) | SiOxD® Wound Matrix | Sioxmed, LLC | Jul 5, 2024 | SESE |
| [K232847](/device/K232847.md) | SiOxD Wound Matrix | Sioxmed, LLC | Dec 18, 2023 | SESE |
| [K223725](/device/K223725.md) | Restrata® MiniMatrix | Acera Surgical, Inc. | May 18, 2023 | SESE |
| [K222189](/device/K222189.md) | SiOxD Wound Matrix | Sioxmed, LLC | Nov 18, 2022 | SESE |
| [K221686](/device/K221686.md) | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | Sep 15, 2022 | SESE |
| [K193583](/device/K193583.md) | Restrata® | Acera Surgical, Inc. | Sep 25, 2020 | SESE |
| [K173544](/device/K173544.md) | Phoenix Wound Matrix | Nanofiber Solutions, Inc. | Mar 2, 2018 | SESE |
| [K172140](/device/K172140.md) | 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](/device/K170213.md) | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations, GmbH | Jun 28, 2017 | SESE |
| [K170300](/device/K170300.md) | Restrata Wound Matrix | Acera Surgical, Inc. | Apr 26, 2017 | SESE |
| [K161067](/device/K161067.md) | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” | Engineered Tissue Solutions, LLC | Sep 15, 2016 | SESE |
| [K142879](/device/K142879.md) | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | Dec 23, 2015 | SESE |
| [K132397](/device/K132397.md) | GORE BIO-A WOUND MATRIX | W. L. Gore & Associates, Inc. | May 7, 2014 | SESE |
| [K090160](/device/K090160.md) | SUPRATHEL WOUND AND BURN DRESSING | Polymedics Innovations, GmbH | May 20, 2009 | SESE |
| [K073251](/device/K073251.md) | HYALOMATRIX PA | Fidia Advanced Biopolymers Srl | Dec 14, 2007 | SESE |
| [K031684](/device/K031684.md) | 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

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**Source:** [https://fda.innolitics.com/productcode/QSZ](https://fda.innolitics.com/productcode/QSZ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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