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510(k) Data Aggregation

    K Number
    K062563
    Device Name
    FEMTEN CERVICAL TENACULUM
    Manufacturer
    FEM SUITE, L.L.C.
    Date Cleared
    2007-05-18

    (260 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEM SUITE, L.L.C.

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

    The FemSuite, LLC, FemTen™ Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "FemTen™ Cervical Tenaculum". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document discusses the regulatory classification of the device, its intended use, and the FDA's determination of substantial equivalence to previously marketed devices. However, there is no mention of performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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

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