BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EXEL INDWELLING CATHETER

    K Number: K895772 · Decision Feb 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    18
    Review Days
    143

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    Basic Information

    Device Name
    EXEL INDWELLING CATHETER
    K Number
    K895772
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Exel Intl.
    Date Received
    September 26, 1989
    Decision Date
    February 16, 1990
    Product Code
    FDZ
    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
    FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens

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