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510(k) Data Aggregation

    K Number
    K992345
    Device Name
    CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
    Manufacturer
    INNERVISION, INC.
    Date Cleared
    1999-09-10

    (89 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

    The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Christoudias Slim Tip Electrode Insert." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods typical for AI/ML device evaluations. Such details are usually found in the 510(k) submission summary or the actual study reports, not in the clearance letter itself.

    Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the provided text.

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