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

    ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U

    K Number: K090547 · Decision Mar 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    645
    Review Days
    16

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    Basic Information

    Device Name
    ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
    K Number
    K090547
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    March 2, 2009
    Decision Date
    March 18, 2009
    Product Code
    NEU
    Advisory Committee
    General, Plastic Surgery
    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
    NEU Marker, Radiographic, Implantable

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