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

    Nasogastric Feeding Tubes - ENFit Port - PVC

    K Number: K213258 · Decision Jun 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    8
    Review Days
    252

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    Basic Information

    Device Name
    Nasogastric Feeding Tubes - ENFit Port - PVC
    K Number
    K213258
    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
    September 30, 2021
    Decision Date
    June 9, 2022
    Product Code
    PIF
    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
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by Cair Lgl

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    K171118 Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
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