BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    TSK Syringe

    K Number: K250127 · Decision Jul 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    194

    Basic Information

    Device Name
    TSK Syringe
    K Number
    K250127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tsk Laboratory, Japan
    Date Received
    January 17, 2025
    Decision Date
    July 30, 2025
    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 Tsk Laboratory, Japan

    K Number Device Name
    K250284 TSK SELECT™ Needle
    K970370 TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE