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FDA 510(k)

TRAUMAGEL® 2.0 Hemostatic Gel

K-Number: K253609 · 2025-12-12

ApplicantCresilon, Inc.
Decision Date2025-12-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

TRAUMAGEL® 2.0 Hemostatic Gel is a medical device manufactured by Cresilon, Inc.. It received FDA 510(k) clearance on 2025-12-12 under approval number K253609. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMAGEL® 2.0 Hemostatic Gel?

TRAUMAGEL® 2.0 Hemostatic Gel is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Cresilon, Inc.. The 510(k) number is K253609.

When was TRAUMAGEL® 2.0 Hemostatic Gel approved by the FDA?

TRAUMAGEL® 2.0 Hemostatic Gel received FDA 510(k) clearance on 2025-12-12, under approval number K253609.

What company makes TRAUMAGEL® 2.0 Hemostatic Gel?

TRAUMAGEL® 2.0 Hemostatic Gel is manufactured by Cresilon, Inc..

What is the FDA product code for TRAUMAGEL® 2.0 Hemostatic Gel?

The FDA product code for TRAUMAGEL® 2.0 Hemostatic Gel is QSY.

Other Devices by Cresilon, Inc.

K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) K240713TRAUMAGEL®

Related Devices (Code: QSY)

K161013InnoSEAL Hemostatic PadInnotherapy, Inc. K160679WoundClot9Core Scientific Creation , Ltd. K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc. K160578Nustat XRBeeken Biomedical, LLC K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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