BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

    K Number: K232665 · Decision Jan 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    7
    Review Days
    147

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    Basic Information

    Device Name
    GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
    K Number
    K232665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec
    Date Received
    August 31, 2023
    Decision Date
    January 25, 2024
    Product Code
    EZD
    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
    EZD Catheter, Straight

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