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

    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

    K Number: K213283 · Decision Jun 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    70
    Applicant Total
    7
    Review Days
    264

    Basic Information

    Device Name
    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
    K Number
    K213283
    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 Limited
    Date Received
    October 1, 2021
    Decision Date
    June 22, 2022
    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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