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510(k) Data Aggregation

    K Number
    K020915
    Device Name
    SOPRO LIGHT SOURCES AND ACCESSORIES
    Manufacturer
    SOPRO
    Date Cleared
    2002-06-14

    (85 days)

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

    Sopro Light Sources and accessories are used for the purpose of providing illumination and allow observation of manipulation of body cavities, hollow organs and canals.

    Device Description

    Sopro Light Sources and Accessories

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, or device performance for the "Sopro Light Sources and Accessories". The document is a 510(k) clearance letter from the FDA, which states that the device is substantially equivalent to a legally marketed predicate device. It does not include the detailed technical or clinical study data that would typically contain the requested information.

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