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510(k) Data Aggregation

    K Number
    K970427
    Device Name
    KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY
    Date Cleared
    1997-03-11

    (35 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the upper urinary tract including the ureter and kidney and, using additional accessories, to perform various diagnostic and therapeutic procedures.

    Device Description

    The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are manually operated surgical devices. The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.

    AI/ML Overview

    This 510(k) summary is for a medical device (Flexible Urology Scopes) submitted in 1997. It describes the device and its intended use but does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and study details.

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