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

    CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE

    K Number: K800822 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    18
    Review Days
    64

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    Basic Information

    Device Name
    CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
    K Number
    K800822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kli
    Date Received
    April 14, 1980
    Decision Date
    June 17, 1980
    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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    Other Clearances by Kli

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    K781089 ONE INCISION BI-POLAR ELECTRO. FORCEPS
    K780955 SCISSORS, HOOK, ELECTROSURGICAL
    K780954 SCISSORS, HOOK, ELECTROSURGICAL
    K772297 INSUFFLATOR, MODEL G100 & 200
    K772242 LAPAROSCOPY CONSOLE MODEL VIII
    K772220 PROBE, COAGULATION ACCESSORY
    K772185 LAPAROSCOPE W/REMOVABLE OPTICS
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