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FDA 510(k)

Axiostat Chitosan Hemostatic Dressing

K-Number: K172324 · 2018-02-23

ApplicantAdvamedica, Inc.
Decision Date2018-02-23
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Axiostat Chitosan Hemostatic Dressing is a medical device manufactured by Advamedica, Inc.. It received FDA 510(k) clearance on 2018-02-23 under approval number K172324. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiostat Chitosan Hemostatic Dressing?

Axiostat Chitosan Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by Advamedica, Inc.. The 510(k) number is K172324.

When was Axiostat Chitosan Hemostatic Dressing approved by the FDA?

Axiostat Chitosan Hemostatic Dressing received FDA 510(k) clearance on 2018-02-23, under approval number K172324.

What company makes Axiostat Chitosan Hemostatic Dressing?

Axiostat Chitosan Hemostatic Dressing is manufactured by Advamedica, Inc..

What is the FDA product code for Axiostat Chitosan Hemostatic Dressing?

The FDA product code for Axiostat Chitosan Hemostatic Dressing is QSY.

Other Devices by Advamedica, Inc.

K202830Axiostat Patch K212766Maxiocel Chitosan Wound Dressing K222909Axiostat Gauze K213198Ax-Surgi Surgical Hemostat

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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