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510(k) Data Aggregation

    K Number
    K232942
    Device Name
    G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-01-30

    (132 days)

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

    G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

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

    The G-Vitri™ Vitrification Freeze Media is indicated for use in the vitrification of occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

    The G-Vitri™ Vitrification Thawing Media is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for G-Vitri™ Vitrification Freeze Media and G-Vitri™ Vitrification Thawing Media. The document focuses on regulatory approval and does not contain information about the device's technical acceptance criteria or a study proving those criteria.

    Therefore, I cannot provide the requested information, which typically pertains to performance studies for medical devices with algorithmic components or diagnostic functions. The G-Vitri™ products are reproductive media and supplements, and their clearance is based on substantial equivalence to predicate devices, rather than a quantifiable performance study against specific acceptance criteria as detailed in your request.

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