BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LYSONIX IRRIGATION SYSTEM

    K Number: K974233 · Decision Feb 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    83

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    Basic Information

    Device Name
    LYSONIX IRRIGATION SYSTEM
    K Number
    K974233
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lysonix, Inc.
    Date Received
    November 12, 1997
    Decision Date
    February 3, 1998
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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    Other Clearances by Lysonix, Inc.

    K Number Device Name
    K980771 LYSONIX SUCTION LIPOPLASTY SYSTEM
    K980763 LYSONIX LIPOPLASTY ACCESS PORT
    K980454 LYSONIX ASPIRATION PUMP
    K972958 LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS