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

    Tenex Health TX System with the TXP MicroTip

    K Number: K181367 · Decision Aug 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    Tenex Health TX System with the TXP MicroTip
    K Number
    K181367
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tenex Health, Inc.
    Date Received
    May 23, 2018
    Decision Date
    August 28, 2018
    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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    Other Clearances by Tenex Health, Inc.

    K Number Device Name
    K153299 Tenex Health TX System