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510(k) Data Aggregation

    K Number
    K013730
    Device Name
    ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2002-02-06

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES

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

    The Novasys "Ariel" RF Electrosurgical Control Module and Accessories, in combination with various Novasys electrodes, is indicated for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

    Device Description

    Novasys "Ariel" RF Electrosurgical Control Module and Accessories

    AI/ML Overview

    This 510(k) premarket notification for the Novasys "Ariel" RF Electrosurgical Control Module and Accessories does not contain the requested information regarding acceptance criteria, device performance studies, or ground truth establishment.

    The provided document is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an Indications for Use statement. These documents primarily confirm the device's classification, intended use, and substantial equivalence to legally marketed predicate devices, allowing it to proceed to market. They do not detail the specific performance studies, acceptance criteria, or experimental methodologies that would be found in a more comprehensive technical report or clinical study summary.

    Therefore, I cannot provide the requested information.

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