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

    Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

    K Number: K221593 · Decision Nov 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    7
    Review Days
    168

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    Basic Information

    Device Name
    Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
    K Number
    K221593
    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, Inc.
    Date Received
    June 2, 2022
    Decision Date
    November 17, 2022
    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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