BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CORTRAK* 2 Enteral Access System (20-0950)

    K Number: K240965 · Decision Jun 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    CORTRAK* 2 Enteral Access System (20-0950)
    K Number
    K240965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avanos Medical, Inc.
    Date Received
    April 9, 2024
    Decision Date
    June 6, 2024
    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 Avanos Medical, Inc.

    K Number Device Name
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