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510(k) Data Aggregation

    K Number
    K250400
    Device Name
    Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
    Date Cleared
    2025-05-09

    (86 days)

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

    Vigeon Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is indicated for use in minimally invasive procedures for removing smoke generated by electrocautery and small amount of fluids when used in conjunction with an effective suction equipment.
    Device Description
    The smoke evacuator has two parts - the exhaust tube and the control valve. The product can be installed on 5mm surgical electrode/high-energy instrument in minimally invasive surgery. The product is connected with the vacuum suction system, using negative pressure to extract smoke, small amount of blood and water from the tip of the surgical instrument.
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