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510(k) Data Aggregation

    K Number
    K180999
    Device Name
    Mygen V-1000 RF System
    Manufacturer
    RF Medical Co., Ltd
    Date Cleared
    2018-12-11

    (239 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K193355,K221277
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

    Device Description

    Electrosurgical, cutting & coagulation device & accessories

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Mygen V-1000 RF System" does not contain any information regarding acceptance criteria, study details (like sample size, ground truth, expert qualifications, or MRMC studies), or performance metrics beyond the simple statement of "substantial equivalence" to a predicate device.

    The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements, but it does not delve into the specific technical studies or performance data typically found in a clinical study report or a detailed 510(k) summary (which might be a separate, more extensive document).

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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