PuraStat— 510(k) K253924

Name: FDA 510(k) clearance K253924
Creator: U.S. Food and Drug Administration
Published: 2026-01-07

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. Device class: 2.

Clearance details

Applicant: 3-D Matrix Europe SAS
Product code: Code QAU
Device class: Class 2
Regulation: 21 CFR 878.4456
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 ↗

Recent devices under product code QAU

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K261503 — PuraStat GI2026-08-03
K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])2026-06-02
K240994 — Nexpowder2024-11-27
K242250 — PuraStat2024-10-22
K234131 — Resolv Endoscopic Hemostat System2024-07-26

More clearances from 3-D Matrix Europe SAS

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K253923 — PuraStat2026-01-07
K242634 — PuraStat2025-01-15

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.