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510(k) Data Aggregation

    K Number
    K253411
    Device Name
    Miniature Telescope for Urology (27033AA)
    Manufacturer
    Karl Storz Se & Co.Kg
    Date Cleared
    2025-11-18

    (49 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For telescope (27033AA)
    The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

    Device Description

    The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that utilizes fiber optic technology. The shaft of the endoscope consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. The Miniature Telescope for Urology (27033AA) is just an optic, without a working or irrigation channel. It is always used in combination (e.g. with sheath (or working element and sheath). Thus providing instruments access to the operative site.

    The Miniature Telescope for Urology (27033AA) is available in the following:
    Direction of View: 0°
    Field of View: 72.5°
    Diameter: 3.5Fr
    Working Length: 21cm

    AI/ML Overview

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