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

    [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]

    K Number: K962506 · Decision Sep 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
    K Number
    K962506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynecare Innovation Center
    Date Received
    June 27, 1996
    Decision Date
    September 16, 1996
    Product Code
    FJL
    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
    FJL Resectoscope

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