TRAUMAGEL® 2.0 Hemostatic Gel— 510(k) K253609

Name: FDA 510(k) clearance K253609
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Substantially Equivalent

Cresilon, Inc.

FDA 510(k) clearance K253609 for TRAUMAGEL® 2.0 Hemostatic Gel, Substantially Equivalent on 2025-12-12. Applicant: Cresilon, Inc.. Device class: Unclassified.

Clearance details

Applicant: Cresilon, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-11-18
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSY

view all

K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)2026-04-30
K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
K250319 — MFUSE (MS001)2025-12-15
K240713 — TRAUMAGEL®2024-08-14
K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)2024-05-22

More clearances from Cresilon, Inc.

view all

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.