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

    PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

    K Number: K181292 · Decision Nov 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
    K Number
    K181292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4710
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cogentix Medical, Inc.
    Date Received
    May 16, 2018
    Decision Date
    November 15, 2018
    Product Code
    EOX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOX Esophagoscope (Flexible Or Rigid)

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    Other Clearances by Cogentix Medical, Inc.

    K Number Device Name
    K253905 PrimeSight UltraView System