BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    ENFit enteral syringes (NUTRIFIT)

    K Number: K211661 · Decision Feb 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    3
    Review Days
    272

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    Basic Information

    Device Name
    ENFit enteral syringes (NUTRIFIT)
    K Number
    K211661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentaferte Italia S.R.L.
    Date Received
    June 1, 2021
    Decision Date
    February 28, 2022
    Product Code
    PNR
    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
    PNR Enteral Syringes With Enteral Specific Connectors

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    Other Clearances by Pentaferte Italia S.R.L.

    K Number Device Name
    K214080 Pentaflush
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