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510(k) Data Aggregation

    K Number
    K233036
    Device Name
    Ultrasonic Surgical System
    Manufacturer
    Hunan Handlike Minimally Invasive Surgery Co., Ltd.
    Date Cleared
    2024-06-18

    (267 days)

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

    Hunan Handlike Minimally Invasive Surgery Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.
    Device Description
    Ultrasonic Surgical System is an ultrasonic dissection and coagulation system composed of four components: Ultrasonic Generator (HD-CSD01), Hand Piece (HD-CSH01), a disposable Ultrasonic Shears includes 4 shaft lengths (HD-CS-DJ45, HD-CS-DJ36, HD-CS-DJ22, HD-CS-DJ14) and foot switch (HRF-M52). A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery. This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.
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    K Number
    K171825
    Device Name
    Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
    Manufacturer
    Hunan Handlike Minimally Invasive Surgery Co., Ltd
    Date Cleared
    2018-02-13

    (239 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hunan Handlike Minimally Invasive Surgery Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.
    Device Description
    Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.
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