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

    CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM

    K Number: K081459 · Decision Aug 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    10
    Review Days
    82

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    Basic Information

    Device Name
    CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
    K Number
    K081459
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Radionics, Inc.
    Date Received
    May 23, 2008
    Decision Date
    August 13, 2008
    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 Integra Radionics, Inc.

    K Number Device Name
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    K100417 XKNIFE 5
    K090864 CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
    K083414 RADIONICS XKNIFE HDRT SYSTEM
    K072454 INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
    K071669 INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
    K063230 INTEGRA RADIONICS IMAGEFUSION 3
    K061893 INTEGRA RADIONICS XKNIFE RT 4