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
    138
    Registration Numbers
    138
    Same Product Code
    155
    Applicant Total
    1
    Review Days
    267

    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.

    SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Tenex 2nd Generation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CUSA® Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CUSA Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    neXus Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all