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

    Wellead® Latex Foley Catheter

    K Number: K233094 · Decision Jun 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    254

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    Basic Information

    Device Name
    Wellead® Latex Foley Catheter
    K Number
    K233094
    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 (Hainan) Co., Ltd.
    Date Received
    September 26, 2023
    Decision Date
    June 6, 2024
    Product Code
    MJC
    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
    MJC Catheter, Urological (Antimicrobial) And Accessories

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