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510(k) Data Aggregation

    K Number
    K190168
    Device Name
    Aquas Probes
    Manufacturer
    Genicon, Inc.
    Date Cleared
    2019-03-14

    (42 days)

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

    Genicon, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.
    Device Description
    The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.
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