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510(k) Data Aggregation

    K Number
    K040834
    Device Name
    NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2004-06-03

    (64 days)

    Product Code
    HAW,IIA
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000

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

    Intended Use: The Navigus Passive Probe (BL) is intended to be used for trajectory navigation in conjunction with the Navigus family of Image-Guided Systems. The device is provided sterile and for single use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Navigus Passive Probe (BL)) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices. It confirms the device can be legally marketed but does not include the detailed study information required to answer your request.

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