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FDA 510(k)

TRAUMAGEL®

K-Number: K240713 · 2024-08-14

ApplicantCresilon, Inc.
Decision Date2024-08-14
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

TRAUMAGEL® is a medical device manufactured by Cresilon, Inc.. It received FDA 510(k) clearance on 2024-08-14 under approval number K240713. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMAGEL®?

TRAUMAGEL® is a medical device that received FDA 510(k) clearance on 2024-08-14. It is manufactured by Cresilon, Inc.. The 510(k) number is K240713.

When was TRAUMAGEL® approved by the FDA?

TRAUMAGEL® received FDA 510(k) clearance on 2024-08-14, under approval number K240713.

What company makes TRAUMAGEL®?

TRAUMAGEL® is manufactured by Cresilon, Inc..

What is the FDA product code for TRAUMAGEL®?

The FDA product code for TRAUMAGEL® is QSY.

Other Devices by Cresilon, Inc.

K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) K253609TRAUMAGEL® 2.0 Hemostatic Gel

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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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