BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇯🇵 Japan

    Ultrasonic Bipolar Generator USG-410 with accessories

    K Number: K211838 · Decision Aug 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    81
    Review Days
    51

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    Basic Information

    Device Name
    Ultrasonic Bipolar Generator USG-410 with accessories
    K Number
    K211838
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corporation
    Date Received
    June 14, 2021
    Decision Date
    August 4, 2021
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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