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

    STERiJECT Low Dead Space, STERiJECT The Invisible Needle

    K Number: K231734 · Decision Mar 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    268

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    Basic Information

    Device Name
    STERiJECT Low Dead Space, STERiJECT The Invisible Needle
    K Number
    K231734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tsk Laboratory International Japan KK
    Date Received
    June 14, 2023
    Decision Date
    March 8, 2024
    Product Code
    QNS
    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
    QNS Low Dead Space Needle, Single Lumen, Hypodermic

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    Other Clearances by Tsk Laboratory International Japan KK

    K Number Device Name
    K242073 STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)