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

    Auto Disable Syringe

    K Number: K210464 · Decision Aug 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    12
    Review Days
    189

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    Basic Information

    Device Name
    Auto Disable Syringe
    K Number
    K210464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    February 16, 2021
    Decision Date
    August 24, 2021
    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 Anhui Tiankang Medical Technology Co., Ltd.

    K Number Device Name
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    K222773 Feeding Tube
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    K222385 Bifurcated Needle
    K220204 Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
    K212368 Surgical Face Mask
    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. →