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510(k) Data Aggregation

    K Number
    K022332
    Device Name
    LITE MINERAL OIL
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2002-08-23

    (36 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LITE MINERAL OIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lite oil is used as an in vitro oil overlay for gametes and zygotes during storage or manipulation.

    Device Description

    Not Found

    AI/ML Overview

    The provided document, K022332 for Lite™ Mineral Oil, is a Premarket Notification (510(k)) from the FDA. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a De Novo or PMA submission.

    Therefore, this document does not contain the specific information required to answer your request about acceptance criteria and a study proving device adherence to those criteria.

    The 510(k) essentially confirms that the device, Lite™ Mineral Oil, is "substantially equivalent" to a previously legally marketed device (a predicate device) for its stated indications for use: "as an in vitro oil overlay for gametes and zygotes during storage or manipulation."

    To provide the information you requested, a different type of regulatory submission or scientific publication would be needed.

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