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

    CYTORI PUREGRAFT 250/PURE SYSTEM

    K Number: K092923 · Decision Jan 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    105

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    Basic Information

    Device Name
    CYTORI PUREGRAFT 250/PURE SYSTEM
    K Number
    K092923
    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
    September 23, 2009
    Decision Date
    January 6, 2010
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

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    Other Clearances by Cytori Therapeutics, Inc.

    K Number Device Name
    K132815 PUREGRAFT 50 SYSTEM
    K113255 PUREGRAFT 850/PURE SYSTEM
    K072587 CYTORI AFT SYSTEM
    K063235 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
    K060482 CYTORI CELUTION CELL CONCENTRATION DEVICE