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FDA 510(k)

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

K-Number: K213652 · 2023-06-28

ApplicantCresilon, Inc.
Decision Date2023-06-28
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is a medical device manufactured by Cresilon, Inc.. It received FDA 510(k) clearance on 2023-06-28 under approval number K213652. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is a medical device that received FDA 510(k) clearance on 2023-06-28. It is manufactured by Cresilon, Inc.. The 510(k) number is K213652.

When was Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) approved by the FDA?

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) received FDA 510(k) clearance on 2023-06-28, under approval number K213652.

What company makes Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is manufactured by Cresilon, Inc..

What is the FDA product code for Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

The FDA product code for Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is QSY.

Other Devices by Cresilon, Inc.

K240713TRAUMAGEL® 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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