FDA product code · General, Plastic Surgery · Class U
QSZ: Absorbable Synthetic Wound Dressing
QSZ is FDA's product code for "Absorbable Synthetic Wound Dressing": a Class U device, reviewed by the General, Plastic Surgery panel.
510(k) review time for QSZ
Across 12 510(k) clearances under QSZ decided from 2018-01-01 to 2026-10-06, the median was 113 days from FDA receipt to decision. Half took between 97 and 173 days, and 80% were decided within 211 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 97 |
| Median | 113 |
| 75th percentile | 173 |
| 80th percentile | 211 |
| 90th percentile | 231 |
| Slowest | 277 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite QSZ
No FDA recognized consensus standard cites QSZ by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.