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

    CUSA NXT EXTENDED LENGTH TIP

    K Number: K102258 · Decision Jun 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    10
    Review Days
    304

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    Basic Information

    Device Name
    CUSA NXT EXTENDED LENGTH TIP
    K Number
    K102258
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Radionics, Inc.
    Date Received
    August 10, 2010
    Decision Date
    June 10, 2011
    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
    K100096 LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
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    K090864 CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
    K083414 RADIONICS XKNIFE HDRT SYSTEM
    K081459 CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION 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