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510(k) Data Aggregation

    K Number
    K051294
    Device Name
    FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2005-12-21

    (217 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1

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

    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for:

    • Cancer screening
    • Endometrial dating
    • Determining response to estrogen replacement therapy
    • Bacterial culturing
    • Detection of pathology resulting in infertility
    • Monitoring patients receiving Tamoxifen therapy
    • Evaluating secondary amenorrhea
    Device Description

    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.

    AI/ML Overview

    The provided text describes the 510(k) clearance for the FemTest™ Endometrial Suction Curette. This document is a regulatory approval, not a scientific study describing performance criteria and results of a device.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain such details. It is a regulatory letter confirming substantial equivalence to a legally marketed predicate device, not a performance study.

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