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

    Radiance Ultra Series ZeroWire Embedded

    K Number: K161228 · Decision May 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    24

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    Basic Information

    Device Name
    Radiance Ultra Series ZeroWire Embedded
    K Number
    K161228
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nds Surgical Imaging, LLC
    Date Received
    May 2, 2016
    Decision Date
    May 26, 2016
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Nds Surgical Imaging, LLC

    K Number Device Name
    K222890 RADIANCE ULTRA 32 4K ZEROWIRE DUO
    K170598 ZeroWire Mobile
    K151609 ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2