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

    Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

    K Number: K250032 · Decision Jul 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    353
    Applicant Total
    10
    Review Days
    184

    Basic Information

    Device Name
    Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
    K Number
    K250032
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    January 7, 2025
    Decision Date
    July 10, 2025
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    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
    KNW Instrument, Biopsy

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