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    K Number
    K092980
    Device Name
    PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2010-03-11

    (164 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5

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

    This Utenine Manipulator Injector (Model UMI-4,5) is indicated for use in Diagnostic Laparotomy, Minilaparotomy, Fertility, Examinations, and Salpingoplastic procedures where manification of the uterus is required. This product also facilitates, the sealing of cervical os while providing a fluid injection port.

    Device Description

    Panpac Uterine Manipulator Injector, Model UMI-4.5

    AI/ML Overview

    I apologize, but the provided text focuses on an FDA clearance letter for a medical device called the "Panpac Uterine Manipulator Injector (Model UMI - 4.5)". This type of document is a regulatory approval, not a scientific study report.

    Therefore, the information required to populate a table of acceptance criteria, device performance, and details about a study with sample sizes, expert qualifications, adjudication methods, or ground truth types is not present in the provided text.

    The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory standard, not a performance metric from a specific study as you've requested. It primarily deals with the administrative aspects of FDA clearance.

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