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

    GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE

    K Number: K933174 · Decision Apr 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    4
    Review Days
    276

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    Basic Information

    Device Name
    GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
    K Number
    K933174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Greenwald Surgical Co., Inc.
    Date Received
    June 29, 1993
    Decision Date
    April 1, 1994
    Product Code
    FAS
    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
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by Greenwald Surgical Co., Inc.

    K Number Device Name
    K933173 GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
    K933175 GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
    K780137 CLAMP, INCONTINENCE, BAUMRUCKER