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

    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

    K Number: K231363 · Decision Sep 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    5
    Review Days
    139

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    Basic Information

    Device Name
    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
    K Number
    K231363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hantech Medical Device Co., Ltd.
    Date Received
    May 11, 2023
    Decision Date
    September 27, 2023
    Product Code
    NGT
    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
    NGT Saline, Vascular Access Flush

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    Other Clearances by Hantech Medical Device Co., Ltd.

    K Number Device Name
    K222739 Disposable Insulin Pen Needle
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