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510(k) Data Aggregation

    K Number
    K242043
    Device Name
    Sperm Freezing Medium
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2025-01-08

    (180 days)

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

    Sperm Freezing Medium

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

    Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about the acceptance criteria or a study proving that a device meets such criteria.

    The document is an FDA 510(k) clearance letter for a device named "Sperm Freezing Medium." This letter confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory requirements, such as general controls, quality systems, and UDI, but it does not include any details about performance criteria or studies conducted by the manufacturer to demonstrate the device's performance.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.

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