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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ENFit Adaptor

    K Number: K233190 · Decision Jan 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    8
    Applicant Total
    15
    Review Days
    112

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    Basic Information

    Device Name
    ENFit Adaptor
    K Number
    K233190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Caina Medical Co.,Ltd
    Date Received
    September 28, 2023
    Decision Date
    January 18, 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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