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

    ENDOSCOPE AND ACCOSSORIES

    K Number: K926004 · Decision Feb 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    7
    Review Days
    75

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    Basic Information

    Device Name
    ENDOSCOPE AND ACCOSSORIES
    K Number
    K926004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endomedix
    Date Received
    November 27, 1992
    Decision Date
    February 10, 1993
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Endomedix

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    K922837 S1500 XENON LIGHT SOURCE
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