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510(k) Data Aggregation

    K Number
    K052878
    Device Name
    NT-1000
    Manufacturer
    NEUROTHERM, INC.
    Date Cleared
    2006-01-23

    (103 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NT-1000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath™ and Acutherm™ catheters, and Radionics DiskTrode™ radiofrequency probes.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a clearance letter from the FDA for a 510(k) premarket notification, indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics.

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