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

    TK Pre-Filled Normal Saline Flush Syringe

    K Number: K230756 · Decision Aug 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    12
    Review Days
    145

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    Basic Information

    Device Name
    TK Pre-Filled Normal Saline Flush Syringe
    K Number
    K230756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    March 20, 2023
    Decision Date
    August 12, 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 Anhui Tiankang Medical Technology Co., Ltd.

    K Number Device Name
    K222772 Oral/Enteral Syringe with ENFit connector
    K222773 Feeding Tube
    K222385 Bifurcated Needle
    K220204 Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
    K212368 Surgical Face Mask
    K210464 Auto Disable Syringe
    K191639 TK Insulin Syringe with/without Saftey Retractable Device
    K191640 TK Intravascular Administration Set
    K191644 TK Safety Needle
    K191642 TK Sterile Piston Syringe without Needle
    Search all 12 clearances from Anhui Tiankang Medical Technology Co., Ltd. →