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

    Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

    K Number: K231299 · Decision Jan 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    263

    Basic Information

    Device Name
    Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
    K Number
    K231299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cair LGL
    Date Received
    May 4, 2023
    Decision Date
    January 22, 2024
    Product Code
    PIO
    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
    PIO Enteral Specific Transition Connectors

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