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510(k) Data Aggregation

    K Number
    K211019
    Device Name
    Disposable Monopolar Laparoscopic Tips and Reusable Handles
    Manufacturer
    Dannik LLC
    Date Cleared
    2021-10-28

    (206 days)

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

    Dannik LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
    Device Description
    The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors. The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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    K Number
    K210569
    Device Name
    Disposable Monopolar Laparoscopic Shafts and Reusable Handles
    Manufacturer
    Dannik LLC
    Date Cleared
    2021-08-16

    (171 days)

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

    Dannik LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
    Device Description
    The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod. The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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