TRAUMAGEL®— 510(k) K240713

Name: FDA 510(k) clearance K240713
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Cresilon, Inc.

FDA 510(k) clearance K240713 for TRAUMAGEL®, Substantially Equivalent on 2024-08-14. Applicant: Cresilon, Inc.. Device class: Unclassified.

Clearance details

Applicant: Cresilon, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-03-15
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)2024-05-22

More clearances from Cresilon, Inc.

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K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)2023-06-28

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.