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    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    ENDOtube

    K Number: K203350 · Decision Sep 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    1
    Review Days
    320

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    Basic Information

    Device Name
    ENDOtube
    K Number
    K203350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nissha Medical Technologies Sas
    Date Received
    November 13, 2020
    Decision Date
    September 29, 2021
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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