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510(k) Data Aggregation

    K Number
    K013497
    Device Name
    FAS SET #4551
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2001-11-09

    (18 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FAS SET #4551

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

    A follicle aspiration set used for transvaginal harvesting of oocytes from follicles for IVF and ICSI.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA to Gynétics Medical Products N.V. regarding their device, FAS SET #4551 Follicle Aspiration Set. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory responsibilities.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.

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