FDA product code QSZ: Absorbable Synthetic Wound Dressing
QSZ is the FDA product code for absorbable synthetic wound dressing. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 21 510(k) submissions under QSZ, 10 in the last five years, from 12 different applicants. The average 510(k) review took 145 days (median 119); 103 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Absorbable Synthetic Wound Dressing |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for QSZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 88 |
| 2018 | 1 | 106 |
| 2020 | 1 | 277 |
| 2022 | 2 | 108 |
| 2023 | 2 | 126 |
| 2024 | 1 | 25 |
| 2025 | 2 | 127 |
| 2026 | 3 | 156 |
Compare with all 510(k) review times · Search every QSZ clearance
Top QSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polynovo Biomaterials Pty, Ltd. | 5 | 2025-06-20 |
| Sioxmed, LLC | 3 | 2024-07-05 |
| Acera Surgical, Inc. | 3 | 2023-05-18 |
| Polymedics Innovations, GmbH | 2 | 2017-06-28 |
| Anika Therapeutics, Inc. | 1 | 2026-09-02 |
7 more applicants have QSZ clearances. See the full list in Caduvo.
Most recent QSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261311 | Anika Therapeutics, Inc. | HYALOMATRIX | 2026-09-02 | 134 |
| K254256 | Huizhou Foryou Medical Devices Co., Ltd. | LUOFUCON® Wound Matrix | 2026-08-18 | 232 |
| K260020 | Beijing Kreate Medical Co., Ltd. | Redermo Wound Matrix | 2026-04-16 | 101 |
| K251567 | Polynovo Biomaterials Pty, Ltd. | NovoSorb BTM | 2025-06-20 | 29 |
| K242149 | Polynovo Biomaterials Pty, Ltd. | NovoSorb® MTX | 2025-03-05 | 225 |
Recalls for QSZ devices
openFDA lists no recalls for product code QSZ.
Frequently asked questions
What is FDA product code QSZ?
QSZ is the FDA product code for absorbable synthetic wound dressing. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is QSZ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSZ?
Across 21 cleared submissions the average was 145 days from receipt to decision (median 119).
Which companies have the most QSZ clearances?
Polynovo Biomaterials Pty, Ltd. (5); Sioxmed, LLC (3); Acera Surgical, Inc. (3); Polymedics Innovations, GmbH (2); Anika Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSZ
- Run a recall and safety report across every QSZ manufacturer
- Watch product code QSZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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