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

    Nutricair Enteral Syringe with ENFit

    K Number: K231300 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    8
    Review Days
    155

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    Basic Information

    Device Name
    Nutricair Enteral Syringe with ENFit
    K Number
    K231300
    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
    October 6, 2023
    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 Cair Lgl

    K Number Device Name
    K231299 Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
    K213258 Nasogastric Feeding Tubes - ENFit Port - PVC
    K210598 Pediatric Nasogastric Feeding Tubes - Single ENFit Port
    K171117 Carefusion NeutraClear Needle-free connector (EL-NC1000)
    K171118 Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
    K171132 Carefusion NeutraClear Needle-free connector
    K133073 CAIR DRIVE, NEUTRACLEAR