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510(k) Data Aggregation

    K Number
    K092984
    Device Name
    PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2010-04-07

    (191 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used during hysterosonography, hysterosalpingogram, salpingoplasties, and hydrotubation.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Panpac Uterine Injector (UI-4.0, UI-2.0)". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the provided text. This document is purely an FDA clearance notice and does not include the technical study details you are asking for.

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