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

    LYSONIX ASPIRATION PUMP

    K Number: K980454 · Decision Mar 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    5
    Review Days
    41

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    Basic Information

    Device Name
    LYSONIX ASPIRATION PUMP
    K Number
    K980454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lysonix, Inc.
    Date Received
    February 5, 1998
    Decision Date
    March 18, 1998
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Lysonix, Inc.

    K Number Device Name
    K980771 LYSONIX SUCTION LIPOPLASTY SYSTEM
    K980763 LYSONIX LIPOPLASTY ACCESS PORT
    K974233 LYSONIX IRRIGATION SYSTEM
    K972958 LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS