BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Ultrasonic Surgical System

    K Number: K233036 · Decision Jun 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    Ultrasonic Surgical System
    K Number
    K233036
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hunan Handlike Minimally Invasive Surgery Co., Ltd.
    Date Received
    September 25, 2023
    Decision Date
    June 18, 2024
    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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    Other Clearances by Hunan Handlike Minimally Invasive Surgery Co., Ltd.

    K Number Device Name
    K171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument