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

    THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE

    K Number: K113872 · Decision Mar 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    19
    Review Days
    69

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    Basic Information

    Device Name
    THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
    K Number
    K113872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vidacare Corporation
    Date Received
    December 30, 2011
    Decision Date
    March 8, 2012
    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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    K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE
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