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FDA 510(k)

Axiostat Patch

K-Number: K202830 · 2021-04-15

ApplicantAdvamedica, Inc.
Decision Date2021-04-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Patch is a medical device manufactured by Advamedica, Inc.. It received FDA 510(k) clearance on 2021-04-15 under approval number K202830. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Patch?

Axiostat Patch is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Advamedica, Inc.. The 510(k) number is K202830.

When was Axiostat Patch approved by the FDA?

Axiostat Patch received FDA 510(k) clearance on 2021-04-15, under approval number K202830.

What company makes Axiostat Patch?

Axiostat Patch is manufactured by Advamedica, Inc..

What is the FDA product code for Axiostat Patch?

The FDA product code for Axiostat Patch is QSY.

Other Devices by Advamedica, Inc.

K172324Axiostat Chitosan Hemostatic Dressing K212766Maxiocel Chitosan Wound Dressing K222909Axiostat Gauze 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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