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510(k) Data Aggregation

    K Number
    K020560
    Device Name
    WORKBENCH BY <GENX>
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2002-06-19

    (119 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WORKBENCH BY

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

    The Workbench will be used as an accessory item during assisted reproductive procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Workbench™ by ". This document only states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information.

    It does not contain any information regarding:

    • Acceptance criteria for the device's performance.
    • Details of any study conducted to prove the device meets acceptance criteria (such as sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

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

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