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510(k) Data Aggregation

    K Number
    K210567
    Device Name
    Ultrasonic Surgical System
    Date Cleared
    2022-09-30

    (581 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Miconvey Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.
    Device Description
    Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
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