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    K Number
    K191067
    Device Name
    Arc Endocuff Glide AEG110 & AEG120
    Manufacturer
    Boddingtons Plastics Ltd
    Date Cleared
    2019-05-30

    (38 days)

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

    Arc Endocuff Glide AEG110 & AEG120

    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 document is a 510(k) clearance letter from the FDA for a medical device called "Arc Endocuff Glide AEG110 & AEG120." It primarily addresses the regulatory approval of the device and its indications for use. It does not contain information about acceptance criteria, device performance study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval notice, not a study report or technical specification.

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