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

    AED HYSTEROSCOPE AND ACCESSORIES

    K Number: K141515 · Decision Jan 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    8
    Review Days
    212

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    Basic Information

    Device Name
    AED HYSTEROSCOPE AND ACCESSORIES
    K Number
    K141515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Advanced Endoscopy Devices, Inc.
    Date Received
    June 9, 2014
    Decision Date
    January 7, 2015
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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    Other Clearances by National Advanced Endoscopy Devices, Inc.

    K Number Device Name
    K170285 AED Sinuscope
    K102663 AED RESECTOSCOPE
    K081553 AED BIPOLAR FORCEPS, MODEL 13-1646
    K081503 AED MONOPOLAR LAP ACCESSORIES
    K993689 AED CYSTOSCOPE
    K993688 AED LAPAROSCOPE
    K991656 AED ARTHROSCOPE