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510(k) Data Aggregation

    K Number
    K061425
    Device Name
    PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
    Manufacturer
    CAMBRIDGE ENDOSCOPIC DEVICES
    Date Cleared
    2006-08-10

    (79 days)

    Product Code
    GEI
    Regulation Number
    878.4400
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    Applicant Name (Manufacturer) :

    CAMBRIDGE ENDOSCOPIC DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pure Wrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
    Device Description
    The pureWrist™ electrocautery laparoscopic instruments are sterile, single use disposable instruments for use through appropriately sized surgical trocars. The instruments consist of a rotating insulated shaft with a 5mm diameter. The distal end of the shaft has the respective end effector attached (scissors, dissector, or hook). The proximal end of the shaft is attached to an ergonomically shaped handle with a rotating knob that allows the shaft to rotate 360 degrees in either direction. The handle contains the actuation mechanism for the respective end effector. The lever on the handle is compressed and released to activate the instrument jaws or scissor blades. Each instrument has a monopolor cautery connector that extends from the bottom of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and proper generator.
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