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510(k) Data Aggregation

    K Number
    K232911
    Device Name
    KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
    Manufacturer
    Karl Storz Endovision, Inc
    Date Cleared
    2024-06-10

    (265 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Karl Storz Endovision, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The optical component of the KARL STORZ flexible ureteroscope consists of: • A light post connection with screw-on adapters for fiberoptic light cables. • A fiber optic light conductor • An optical image bundle behind an objective lens • A flexible shaft housing • A magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user • A reticle, or marker in the field of view, that indicates the 12 o'clock position as a point of reference The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include: • A working channel that accepts flexible accessories at the proximal end and features a T-LUER Lock fitting for irrigation • A deflection lever, for active distal tip deflection • A proximal strain relief that connects the flexible shaft to the handpiece
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