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

    Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

    K Number: K201840 · Decision Nov 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    6
    Review Days
    125

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    Basic Information

    Device Name
    Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
    K Number
    K201840
    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
    Date Received
    July 2, 2020
    Decision Date
    November 4, 2020
    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

    K Number Device Name
    K203745 AURORA Evacuator +Coag
    K201637 Aurora Evacuator +Coag
    K191861 Aurora Surgiscope System
    K190075 Aurora Evacuator
    K180372 Aurora Evacuator