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

    HYDRASOLVE LIPOPLASTY SYSTEM

    K Number: K130152 · Decision Apr 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    3
    Review Days
    86

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    Basic Information

    Device Name
    HYDRASOLVE LIPOPLASTY SYSTEM
    K Number
    K130152
    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
    Andrew Technologies, LLC
    Date Received
    January 22, 2013
    Decision Date
    April 18, 2013
    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 Andrew Technologies, LLC

    K Number Device Name
    K121218 HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
    K092066 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE