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510(k) Data Aggregation

    K Number
    K151801
    Device Name
    Arc Endocuff Vision
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Date Cleared
    2015-08-13

    (42 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K160846,K162205
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
    ·Keeping the suitable depth of endoscope's view field
    •Helping the endoscope with being inserted into the gastrointestinal tract

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Arc Endocuff Vision, a device that attaches to the distal end of an endoscope. The document does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter is an official notification of substantial equivalence determination by the FDA based on the information provided in the 510(k) submission.

    Therefore, I cannot provide the requested information from the given text.

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