BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Introducer Needle

    K Number: K222705 · Decision May 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    257

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    Basic Information

    Device Name
    Introducer Needle
    K Number
    K222705
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Youcare Technology Co.,Ltd. (Wuhan)
    Date Received
    September 7, 2022
    Decision Date
    May 22, 2023
    Product Code
    LJE
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJE Catheter, Nephrostomy

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    Other Clearances by Youcare Technology Co.,Ltd. (Wuhan)

    K Number Device Name
    K230748 Disposable Ureteral Access Sheath