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510(k) Data Aggregation

    K Number
    K182258
    Device Name
    AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-09-21

    (31 days)

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

    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "AquaShield System CO2." It specifies the device's intended use and regulatory classification but does not include information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

    Therefore, I cannot provide the requested information based on the input text.

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