BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Axiostat Patch

    K Number: K202830 · Decision Apr 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    5
    Review Days
    202

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    Basic Information

    Device Name
    Axiostat Patch
    K Number
    K202830
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advamedica, Inc.
    Date Received
    September 25, 2020
    Decision Date
    April 15, 2021
    Product Code
    QSY
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Advamedica, Inc.

    K Number Device Name
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    K222909 Axiostat Gauze
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    K172324 Axiostat Chitosan Hemostatic Dressing