BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    END 200 Endoscopic Tubeset

    K Number: K202922 · Decision Jul 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    282

    Basic Information

    Device Name
    END 200 Endoscopic Tubeset
    K Number
    K202922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Palliare Ltd.
    Date Received
    September 29, 2020
    Decision Date
    July 8, 2021
    Product Code
    FCX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

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