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

    Kogent Torus Ultrasonic Aspirator

    K Number: K192963 · Decision Jun 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    7
    Review Days
    240

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    Basic Information

    Device Name
    Kogent Torus Ultrasonic Aspirator
    K Number
    K192963
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Katalyst Surgical, LLC
    Date Received
    October 23, 2019
    Decision Date
    June 19, 2020
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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    K140362 KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
    K123172 KOGENT BIPOLAR FORCEPS
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