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510(k) Data Aggregation

    K Number
    K072811
    Device Name
    MARIONETTE SA, MODEL 001 001 & 001 002
    Manufacturer
    KINETIC SURGICAL LLC
    Date Cleared
    2008-04-21

    (203 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KINETIC SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
    Device Description
    The Marionette™ SA is a manually operated, articulating mechanical surgical device. It is primarily composed of stainless steel, anodized aluminum and Delrin. The instrument provides for the one handed control (left or right hand) of the positioning/repositioning of an instrument that includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components.
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    K Number
    K061292
    Device Name
    STATARIUS, MODEL 001 003
    Manufacturer
    KINETIC SURGICAL LLC
    Date Cleared
    2006-07-03

    (55 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KINETIC SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Statarius™ is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
    Device Description
    The Statarius™ is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The Statarius™ eliminates the need for the surgeon or assistant to continuously hold an endoscope during surgical procedures.
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