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    K Number
    K050772
    Device Name
    NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2005-04-21

    (27 days)

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

    NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000

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

    Intended Use: The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.

    Device Description

    Navigus Reusable Passive Probe

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth. The document is an FDA 510(k) clearance letter for a medical device (Navigus Reusable Passive Probe), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not the technical details of a study or performance criteria.

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