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

    Flexible HD Cysto-Urethroscope System

    K Number: K182723 · Decision Apr 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    334
    Review Days
    207

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    Basic Information

    Device Name
    Flexible HD Cysto-Urethroscope System
    K Number
    K182723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    September 28, 2018
    Decision Date
    April 23, 2019
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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