PuraStat— 510(k) K253924

Substantially Equivalent

3-D Matrix Europe SAS

FDA 510(k) clearance K253924 for PuraStat, Substantially Equivalent on 2026-01-07. Applicant: 3-D Matrix Europe SAS.

Clearance details

Applicant: 3-D Matrix Europe SAS
Product code: Code QAU
Advisory panel: General, Plastic Surgery
Date received: 2025-12-08
Decision date: 2026-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Caluire Et Cuire, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code QAU

product code QAU

Death: 6
Injury: 135
Malfunction: 621
Total: 762

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.