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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

    K Number: K231856 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    266

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    Basic Information

    Device Name
    TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
    K Number
    K231856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medexel Co.,Ltd
    Date Received
    June 23, 2023
    Decision Date
    March 15, 2024
    Product Code
    QNQ
    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
    QNQ Low Dead Space Piston Syringe

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    Other Clearances by Medexel Co.,Ltd

    K Number Device Name
    K172095 Autokeeper
    K152410 Top Fine Pen Needle