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

    SAVI PREPARATION DEVICE

    K Number: K101411 · Decision Jul 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    8
    Review Days
    54

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    Basic Information

    Device Name
    SAVI PREPARATION DEVICE
    K Number
    K101411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cianna Medical, Inc.
    Date Received
    May 19, 2010
    Decision Date
    July 12, 2010
    Product Code
    JAQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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    K081677 SAVI APPLICATOR KIT
    K080565 MODIFICATION TO: SAVI APPLICATOR KIT