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

    Aurora Surgiscope System

    K Number: K182211 · Decision Jan 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    156

    Basic Information

    Device Name
    Aurora Surgiscope System
    K Number
    K182211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rebound Therapeutics Corporation
    Date Received
    August 15, 2018
    Decision Date
    January 18, 2019
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWG Endoscope, Neurological

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    Other Clearances by Rebound Therapeutics Corporation

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