BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    LotusCatheter (Lotus No Balloon Catheter)

    K Number: K191512 · Decision May 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    349

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    Basic Information

    Device Name
    LotusCatheter (Lotus No Balloon Catheter)
    K Number
    K191512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Hakki Medical Technologies, Inc.
    Date Received
    June 7, 2019
    Decision Date
    May 21, 2020
    Product Code
    GBM
    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
    GBM Catheter, Urethral

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    Other Clearances by Hakki Medical Technologies, Inc.

    K Number Device Name
    K101900 HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH