LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032208
    Device Name
    MONA LISA ASPIRATION NEEDLE
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    2003-12-09

    (144 days)

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

    MONA LISA ASPIRATION NEEDLE

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

    The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Mona Lisa Aspiration Needle. It primarily concerns the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    Therefore, I cannot provide the requested information based on the given document. The document does not describe a study or specific acceptance criteria for the Mona Lisa Aspiration Needle.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1