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

    AED MONOPOLAR LAP ACCESSORIES

    K Number: K081503 · Decision Sep 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    8
    Review Days
    119

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    Basic Information

    Device Name
    AED MONOPOLAR LAP ACCESSORIES
    K Number
    K081503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Advanced Endoscopy Devices, Inc.
    Date Received
    May 29, 2008
    Decision Date
    September 25, 2008
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by National Advanced Endoscopy Devices, Inc.

    K Number Device Name
    K170285 AED Sinuscope
    K141515 AED HYSTEROSCOPE AND ACCESSORIES
    K102663 AED RESECTOSCOPE
    K081553 AED BIPOLAR FORCEPS, MODEL 13-1646
    K993689 AED CYSTOSCOPE
    K993688 AED LAPAROSCOPE
    K991656 AED ARTHROSCOPE