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510(k) Data Aggregation

    K Number
    K043036
    Device Name
    NON-STICK ELECTRODE
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2005-05-06

    (183 days)

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

    It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Modern Medical Non Stick Electrode." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested table and study details from the given text.

    The information I can extract, which is not directly related to acceptance criteria or performance studies but is present in the document, includes:

    • Trade/Device Name: Modern Medical Non Stick Electrode
    • Regulation Number: 21 CFR 878.4400
    • Regulation Name: Electrosurgical cutting and coagulation device and accessories
    • Regulatory Class: II
    • Product Code: GEI
    • Indications For Use: It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
    • 510(k) Number: K043036
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