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

    Safety Pen Needle

    K Number: K253622 · Decision Mar 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    120

    Basic Information

    Device Name
    Safety Pen Needle
    K Number
    K253622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Medsun Medical Co., Ltd.
    Date Received
    November 18, 2025
    Decision Date
    March 18, 2026
    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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