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510(k) Data Aggregation

    K Number
    K231872
    Device Name
    Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
    Date Cleared
    2023-08-25

    (60 days)

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

    Kirwan Surgical Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General-purpose solid-state bipolar generator used to supply High Frequency currents via electrosurgical handpieces for the function of cutting or coagulating soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
    Device Description
    The proposed Polaris™ Bipolar Electrosurgical Generator System includes a Generator as the main console, a Footswitch, an Irrigation Module, and a Light Source Module. The Generator contains a single bipolar channel for delivery with an electrode applying the energy to the patient. The Irrigation Module connects to tubing that allows fluid to be delivered to the surgical site to allow for clearing of debris from the surgical field. The Light Source Module connects to an optical fiber that supplies illumination to the surgical site to assist with surgeon visualization. The Footswitch is used to control the delivery of RF energy to the patient with one switch for Coagulate and one for Cut power. The Generator includes 4 Module ports for controlling and powering the Modules each have built in cords to connect to these ports on the Generator. The Modules mount to the Generator using a locking rail system so that they will not accidentally come loose during use. The Irrigation Module includes an IV pole that attaches to the Generator to support a saline bag that supplies the irrigation fluid.
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