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510(k) Data Aggregation

    K Number
    K021869
    Device Name
    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
    Manufacturer
    DIROS TECHNOLOGY, INC.
    Date Cleared
    2002-07-01

    (25 days)

    Product Code
    GXD,GXI,GZL
    Regulation Number
    882.4400
    Type
    Special
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

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

    The OWL Radiofrequency System, Model URF-2AP, intended use is for:

    1. lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
    2. radiofrequency heat lesion procedures for the relief of pain.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA regarding a 510(k) premarket notification for a device called the "OWL Radiofrequency System, Model URF-2AP." The letter confirms the device's substantial equivalence to previously marketed devices and lists its indications for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided.

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