BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

    K Number: K191387 · Decision Jun 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    21

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    Basic Information

    Device Name
    ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
    K Number
    K191387
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Envizion Medical , Ltd.
    Date Received
    May 24, 2019
    Decision Date
    June 14, 2019
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Envizion Medical , Ltd.

    K Number Device Name
    K203133 ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
    K182915 ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube