Product code
QSZ: Absorbable synthetic wound dressing
FDA product code · Unclassified · General & Plastic Surgery
Key facts
| Product code | QSZ |
|---|---|
| Device | Absorbable synthetic wound dressing |
| Device class | Unclassified |
| Review panel | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database