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510(k) Data Aggregation

    K Number
    K051831
    Device Name
    GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
    Manufacturer
    APPLIED SURGICAL, LLC
    Date Cleared
    2005-09-07

    (63 days)

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

    APPLIED SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices. The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments. The system is intended for use in hospitals or outpatient clinics.
    Device Description
    The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices. The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.
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