LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120590
    Device Name
    DILATOR TUBE SET
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2013-05-07

    (434 days)

    Product Code
    PDQ,GXZ
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DILATOR TUBE SET

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

    The Dilator Tube Set is intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site and to identify motor nerves, spinal nerve roots and to aid the surgeon in assessing nerve function during surgery. The Dilator Tube Set is single use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a "Dilator Tube Set" and primarily discusses the regulatory approval process and the intended use of the device. It does not include details about performance studies, acceptance criteria, or ground truth establishment.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1