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

    Sertera Biopsy Device

    K Number: K150169 · Decision Aug 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    116
    Review Days
    200

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    Basic Information

    Device Name
    Sertera Biopsy Device
    K Number
    K150169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    January 26, 2015
    Decision Date
    August 14, 2015
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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