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

    DX101-T ULTRASONIC SURGICAL SYSTEM

    K Number: K880815 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    16
    Review Days
    56

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    Basic Information

    Device Name
    DX101-T ULTRASONIC SURGICAL SYSTEM
    K Number
    K880815
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Niic U.S.A., Inc.
    Date Received
    February 17, 1988
    Decision Date
    April 13, 1988
    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 Niic U.S.A., Inc.

    K Number Device Name
    K902133 MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
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    K902063 NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
    K901204 EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
    K900185 NIIC MODEL: DX901 ASPIRATION SYSTEM
    K896988 NIIC LASER SYSTEM
    K895581 MODEL: IR205 ARTICULATED SURGICAL LASER
    K895247 MODEL IR103 SURGICAL LASER SYSTEM
    K892359 MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
    K895239 MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
    Search all 16 clearances from Niic U.S.A., Inc. →