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

    STATSTIX

    K Number: K200764 · Decision Oct 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    STATSTIX
    K Number
    K200764
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centrix Incorporated
    Date Received
    March 24, 2020
    Decision Date
    October 15, 2020
    Product Code
    MVL
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVL Cord, Retraction

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