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510(k) Data Aggregation

    K Number
    K140366
    Device Name
    ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
    Manufacturer
    HOGUE SURGICAL LLC
    Date Cleared
    2014-08-15

    (182 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOGUE SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hogue Surgical EndlessFiber® SMA-BAR family of medical devices is intended for clinical use in laser surgery procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: Y AG, Ho: Y AG, Diode, and KTP laser systems have been cleared for medical use, provided they are fitted with a launch port aperture compatible with the EndlessFiber® SMA 905 connector.
    Device Description
    The Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber is a family of optical fibers that are terminated at one end with industry standard SMA 905 connectors. Each connector is fitted with a collar, a strain relief to the fiber, and a dust cover to protect the mechanically-cleaved fiber endfaces.
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