Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070874
    Date Cleared
    2007-11-02

    (218 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR

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

    Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Arthro Kinetics Vesalius MR Generator. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance, but it does not detail any technical performance criteria or study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1