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

    Insulin Pen Needle

    K Number: K221176 · Decision Jul 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    466
    Registration Numbers
    466
    Same Product Code
    680
    Applicant Total
    9
    Review Days
    67

    Basic Information

    Device Name
    Insulin Pen Needle
    K Number
    K221176
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin Huahong Technology Co., Ltd.
    Date Received
    April 25, 2022
    Decision Date
    July 1, 2022
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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