BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NuStat

    K Number: K183190 · Decision Sep 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    310

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    Basic Information

    Device Name
    NuStat
    K Number
    K183190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4454
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beeken Biomedical, LLC
    Date Received
    November 19, 2018
    Decision Date
    September 25, 2019
    Product Code
    POD
    Advisory Committee
    General, Plastic Surgery
    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
    POD Temporary, Internal Use Hemostatic

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