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510(k) Data Aggregation

    K Number
    K052192
    Device Name
    FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2006-02-02

    (175 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I

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

    The FemSpec, LLC, FemSpec-Sterile™ Disposable Sterile Vaginal Speculum is indicated for diagnostic procedures of the cervix.

    Device Description

    FemSpec, LLC, FemSpec-Sterile™ Disposable Sterile Vaginal Speculum

    AI/ML Overview

    This document is a 510(k) clearance letter for the FemSpec, LLC, FemSpec-Sterile™ Disposable Sterile Vaginal Speculum. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    Crucially, this document is a regulatory approval notice and does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory compliance and the determination of substantial equivalence, not on specific performance metrics or clinical study results.

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