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

    ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380

    K Number: K060323 · Decision May 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    231
    Review Days
    92

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    Basic Information

    Device Name
    ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
    K Number
    K060323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    February 9, 2006
    Decision Date
    May 12, 2006
    Product Code
    MQR
    Advisory Committee
    General, Plastic Surgery
    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
    MQR Stent, Colonic, Metallic, Expandable

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