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

    AED RESECTOSCOPE

    K Number: K102663 · Decision Dec 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    106

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    Basic Information

    Device Name
    AED RESECTOSCOPE
    K Number
    K102663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Advanced Endoscopy Devices, Inc.
    Date Received
    September 15, 2010
    Decision Date
    December 30, 2010
    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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    Other Clearances by National Advanced Endoscopy Devices, Inc.

    K Number Device Name
    K170285 AED Sinuscope
    K141515 AED HYSTEROSCOPE AND ACCESSORIES
    K081553 AED BIPOLAR FORCEPS, MODEL 13-1646
    K081503 AED MONOPOLAR LAP ACCESSORIES
    K993689 AED CYSTOSCOPE
    K993688 AED LAPAROSCOPE
    K991656 AED ARTHROSCOPE