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510(k) K253609

TRAUMAGEL® 2.0 Hemostatic Gel by Cresilon, Inc. — Product Code QSY

K253609 is an FDA 510(k) premarket notification submitted by Cresilon, Inc. for the device "TRAUMAGEL® 2.0 Hemostatic Gel". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Cresilon, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
November 18, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Cresilon, Inc.

  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (June 28, 2023)

Other clearances for product code QSY

  • K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20) (April 30, 2026)
  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)

FDA data resources