BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GYRUS ENDOUROLOGY SYSTEM

    K Number: K990628 · Decision Jun 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    8
    Review Days
    124

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    Basic Information

    Device Name
    GYRUS ENDOUROLOGY SYSTEM
    K Number
    K990628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Medical , Ltd.
    Date Received
    February 25, 1999
    Decision Date
    June 29, 1999
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Gyrus Medical , Ltd.

    K Number Device Name
    K041285 GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
    K003569 PLASMAKINETIC ENDOUROLOGY SYSTEM
    K001270 GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
    K994166 GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
    K993749 GYRUS HYSTEROSCOPIC RESECTOSCOPE
    K982771 GYRUS HYSTEROSCOPIC RESECTOSCOPE
    K891681 DILECTRON URINARY CONDUCTIVITY PROBE