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510(k) Data Aggregation

    K Number
    K984552
    Device Name
    COOL-TIP RF SYSTEM
    Manufacturer
    RADIONICS, INC.
    Date Cleared
    1999-03-05

    (73 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K000944,K040763,K042216,K052796,K052919,K062935,K070101,K070356,K070446,K072261,K072870,K120116
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Radionics, Inc. Cool-Tip RF System, dated March 5, 1999. This document only states the FDA's finding of substantial equivalence based on a premarket notification. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

    The letter focuses on the regulatory aspects of the device, indicating that it is substantially equivalent to a predicate device and can therefore be marketed.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets those criteria from the provided text.

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