BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    BEXCORE Breast Biopsy System, Biopsy Needle

    K Number: K171890 · Decision Aug 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    1
    Review Days
    420

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    Basic Information

    Device Name
    BEXCORE Breast Biopsy System, Biopsy Needle
    K Number
    K171890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Park Co., Ltd.
    Date Received
    June 26, 2017
    Decision Date
    August 20, 2018
    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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