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510(k) Data Aggregation

    K Number
    K030919
    Device Name
    SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    Manufacturer
    MEDISISS
    Date Cleared
    2003-07-03

    (101 days)

    Product Code
    NLR
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    NLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.
    Device Description
    Reprocessed Electrosurgical Instruments may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (using a knob on the handle.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.
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