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

    3DHJD CAMERA SYSTEM MODEL

    K Number: K101810 · Decision Aug 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    3DHJD CAMERA SYSTEM MODEL
    K Number
    K101810
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision Systems Group, A Division of Viking Systems
    Date Received
    June 29, 2010
    Decision Date
    August 30, 2010
    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 Vision Systems Group, A Division of Viking Systems

    K Number Device Name
    K081585 ENDOSCOPY VIDEO CAMERA SYSTEM