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

    XPress BCD Breast Compression Device

    K Number: K163388 · Decision Jul 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    229

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    Basic Information

    Device Name
    XPress BCD Breast Compression Device
    K Number
    K163388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xpress Bcd, LLC
    Date Received
    December 2, 2016
    Decision Date
    July 19, 2017
    Product Code
    POY
    Advisory Committee
    Radiology
    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
    POY Post Breast Biopsy Hemostatic Breast Compression Device