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

    Cure Catheter Closed System; Cure Dextra Closed System

    K Number: K230400 · Decision Nov 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    7
    Review Days
    266

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    Basic Information

    Device Name
    Cure Catheter Closed System; Cure Dextra Closed System
    K Number
    K230400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Convatec, Inc.
    Date Received
    February 15, 2023
    Decision Date
    November 8, 2023
    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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