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FDA 510(k)

Axiostat Gauze

K-Number: K222909 · 2023-04-07

ApplicantAdvamedica, Inc.
Decision Date2023-04-07
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Gauze is a medical device manufactured by Advamedica, Inc.. It received FDA 510(k) clearance on 2023-04-07 under approval number K222909. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Gauze?

Axiostat Gauze is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Advamedica, Inc.. The 510(k) number is K222909.

When was Axiostat Gauze approved by the FDA?

Axiostat Gauze received FDA 510(k) clearance on 2023-04-07, under approval number K222909.

What company makes Axiostat Gauze?

Axiostat Gauze is manufactured by Advamedica, Inc..

What is the FDA product code for Axiostat Gauze?

The FDA product code for Axiostat Gauze is QSY.

Other Devices by Advamedica, Inc.

K172324Axiostat Chitosan Hemostatic Dressing K202830Axiostat Patch K212766Maxiocel Chitosan Wound Dressing K213198Ax-Surgi Surgical Hemostat

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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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