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510(k) Data Aggregation

    K Number
    K041470
    Device Name
    MORTON IUI CATHETERS
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    2004-11-22

    (173 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MORTON IUI CATHETERS

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

    Insemination Catheters are used for transferring spermatozoa into the uterine cavity.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Morton IUI Catheter) and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

    The letter acknowledges the submission and allows the device to be marketed, subject to general controls. It does not include:

    1. Acceptance criteria table or device performance reports.
    2. Details on sample sizes, data provenance, or ground truth establishment.
    3. Information on expert qualifications, adjudication methods, or MRMC studies.
    4. Standalone algorithm performance or training set specifics.

    The document is primarily an administrative communication regarding market authorization based on substantial equivalence, not a summary of performance studies.

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