| K-number | K253609 |
| Device name | TRAUMAGEL® 2.0 Hemostatic Gel |
| Applicant | Cresilon, Inc. |
| Product code | QSY |
| Device class | Class U |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
TRAUMAGEL® 2.0 is a hemostatic gel containing chitosan granules suspended in sodium alginate, delivered via a pre-filled syringe. It is indicated for temporary external use to control moderate to severe bleeding by forming a mechanical barrier at the wound site.
The device uses a viscous gel formulation of sodium alginate and chitosan (poly N-acetyl-D-glucosamine, D-glucosamine) in a 30 mL pre-filled syringe with a Tritan copolyester barrel and ABS cap. It is terminally sterilized with gamma irradiation to SAL 10⁻⁶ and supplied in a foil pouch as a single-use device with a six-month shelf life.
ISO 10993-1:2018 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-11 (systemic toxicity), ISO 10993-12:2021 (sample preparation), ISO 10993-4:2017/AMD1:2025 (blood interactions), and USP <151> (pyrogen testing).
The subject device has identical intended use, indications, mechanism of action, and hemostatic gel composition as the primary predicate TRAUMAGEL® (K240713). The syringe material composition matches the additional predicate CHG™ (K213652). Performance testing demonstrates the modifications do not raise new safety or efficacy concerns, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov