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

    Wellead Ureteral Catheter

    K Number: K220036 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    17
    Review Days
    345

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    Basic Information

    Device Name
    Wellead Ureteral Catheter
    K Number
    K220036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well Lead Medical Co., Ltd.
    Date Received
    January 5, 2022
    Decision Date
    December 16, 2022
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOD Catheter, Urological

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