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510(k) Data Aggregation

    K Number
    K981589

    Validate with FDA (Live)

    Device Name
    ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1998-07-30

    (87 days)

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

    Indicated for coagulation of tissue

    These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

    Device Description

    Electrosurgical Basket Electrodes

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "Electrosurgical Basket Electrodes" and an associated "Indications for Use" document. This type of document is an FDA clearance and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

    Therefore, I cannot provide the requested information based on the input.

    To answer your request, I would need a document that describes:

    • A specific device that uses AI or has performance criteria requiring a study.
    • The acceptance criteria for that device.
    • Details of a study performed to demonstrate conformance to those acceptance criteria.
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