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510(k) Data Aggregation

    K Number
    K252208

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-06

    (234 days)

    Product Code
    Regulation Number
    884.4530
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The JFord Speculum Sleeve™ is a single use, inflatable vaginal wall retraction sleeve intended for use with a vaginal speculum to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

    Device Description

    The JFord Speculum Sleeve™ is a single use, non-sterile, inflatable vaginal wall retraction sleeve designed for use with single use or reusable vaginal specula (medium or large sizes). The speculum sleeve, while used with a vaginal speculum, provides lateral displacement of vaginal tissue during routine female pelvic examinations or other gynecological procedures. The speculum sleeve is intended to assist the clinician in examination when challenged by redundant vaginal walls.

    The speculum sleeve has a bottom blade pocket and top sleeve for the speculum blades and bilateral expandable pouches. Using the supplied 30 mL syringe, the expandable pouches are filled as needed with potable water or saline during use to laterally displace redundant vaginal walls to enable optimal visualization.

    AI/ML Overview

    N/A

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