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

    Disposable Insulin Syringe

    K Number: K222672 · Decision Mar 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    5
    Review Days
    181

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    Basic Information

    Device Name
    Disposable Insulin Syringe
    K Number
    K222672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hantech Medical Device Co., Ltd.
    Date Received
    September 6, 2022
    Decision Date
    March 6, 2023
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Hantech Medical Device Co., Ltd.

    K Number Device Name
    K231363 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
    K222739 Disposable Insulin Pen Needle
    K221038 Disposable Medical Masks
    K220603 Disposable Medical Safety Hypodermic Needle