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

    URETHRAL DILATOR ENDOSCOPE

    K Number: K874530 · Decision Jan 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    31
    Applicant Total
    9
    Review Days
    85

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    Basic Information

    Device Name
    URETHRAL DILATOR ENDOSCOPE
    K Number
    K874530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Intervention, Inc.
    Date Received
    November 3, 1987
    Decision Date
    January 27, 1988
    Product Code
    KOB
    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
    KOB Catheter, Suprapubic (And Accessories)

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