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

    Oral/Enteral Syringe

    K Number: K210621 · Decision Apr 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    3
    Review Days
    57

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    Basic Information

    Device Name
    Oral/Enteral Syringe
    K Number
    K210621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Tianyi Medical Appliance Co., Ltd.
    Date Received
    March 2, 2021
    Decision Date
    April 28, 2021
    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 Ningbo Tianyi Medical Appliance Co., Ltd.

    K Number Device Name
    K251442 TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
    K211025 Oral/Enteral Syringe with ENFit connector