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

    CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT

    K Number: K063235 · Decision Jan 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
    K Number
    K063235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytori Therapeutics, Inc.
    Date Received
    October 25, 2006
    Decision Date
    January 24, 2007
    Product Code
    QPB
    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
    QPB System, Suction, Lipoplasty For Removal

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    K060482 CYTORI CELUTION CELL CONCENTRATION DEVICE