LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021737
    Device Name
    REPHRESH VAGINAL GEL
    Manufacturer
    COLUMBIA LABORATORIES, INC.
    Date Cleared
    2002-08-26

    (90 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K091298
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    May be used as a personal lubricant when vaginal dryness causes discomfort. Also eases insertion of tampons.

    Device Description

    RepHresh™ Vaginal Gel Personal Lubricant

    AI/ML Overview

    This document is a 510(k) Substantial Equivalence Determination letter from the FDA for the RepHresh Vaginal Gel™. This letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or, if it has different technological characteristics, these do not raise new questions of safety and effectiveness.

    To fulfill your request, I would need a document that describes the clinical performance or validation studies conducted for the RepHresh Vaginal Gel™, which is not provided in these pages.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1