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

    ENDOTEK ULTRA SYSTEM

    K Number: K920451 · Decision Sep 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    29
    Review Days
    226

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    Basic Information

    Device Name
    ENDOTEK ULTRA SYSTEM
    K Number
    K920451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgitek
    Date Received
    February 4, 1992
    Decision Date
    September 17, 1992
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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