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510(k) Data Aggregation

    K Number
    DEN220047
    Device Name
    Galen ES Cooperative Surgical Assistant Platform, Galen ES
    Manufacturer
    Date Cleared
    2023-07-19

    (362 days)

    Product Code
    Regulation Number
    874.4460
    Why did this record match?
    Product Code :

    QXG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Galen ES is intended to assist in the movement of the specified Integra Jako Micro Laryngeal Alligator Forceps to a surgeon-selected position within a surgical field and remain in place until moved elsewhere by the operator. The Galen ES is indicated to be used in rigid microlaryngeal procedures where the specified Jako Micro Laryngeal Alligator Forceps would be utilized by an experienced trained otolaryngologist performing microlaryngeal surgery in an operating room environment in patients at least 18 years old.
    Device Description
    The Galen ES (see Figure 1 and Figure 2) is a cooperatively-controlled surgical assistant platform (i.e., designed to be controlled by direct user interaction with the surgical instrument), intended to assist in the manipulation of the Integra Jako Micro Laryngeal Alligator Forceps (Integra Part# 3731042 serrated 9.0mm, straight 9.25 inch (235 mm)) (see Figure 3). NOTE: The Integra Jako Micro Laryngeal Alligator Forceps will not be provided with the system. The Galen ES is designed to work with the surgeon by sensing the physical forces and movements applied by the surgeon to the Integra Jako Micro Laryngeal Alligator Forceps connected to the Galen ES and successively moving the instrument in a manner consistent with the forces applied.
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