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510(k) Data Aggregation

    K Number
    K023051
    Device Name
    INTRAUTERINE DELIVERY SYSTEM - INJECTOR
    Manufacturer
    PROSURG, INC.
    Date Cleared
    2002-12-12

    (90 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

    The Intrauterine delivery system is used to deliver and fill uterine cavity with sterile imaging agents or injection media for ultrasound imaging, diagnosis and treatment of uterine disorders. The injection media /agents can be saline, contrast agents, or other sonography media / agents in liquid, viscous gel or suspension form to conform the interior of the uterine cavity.

    The Uterine delivery catheter device is designed to facilitate the sealing of the cervical os during injection procedure.

    Device Description

    Intrauterine Delivery System - Injector

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Intrauterine Delivery System- Injector (K023051). It does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details various regulatory compliance requirements but does not include any performance data or study results.

    Therefore, I cannot provide the requested information based on the text provided.

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