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510(k) Data Aggregation

    K Number
    K020726
    Device Name
    DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2002-05-15

    (70 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K052314
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dukal Disposable Vaginal Speculum is used to expose the interior of the vagina.

    Device Description

    The Dukal Disposable Vaginal Speculum

    AI/ML Overview

    The provided text describes a 510(k) summary and FDA clearance letter for the Dukal Vaginal Speculum. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device performance.

    The document is a regulatory filing for a manual medical device (a vaginal speculum), not an AI/software device that would typically involve such studies and performance metrics. Therefore, I cannot extract the requested information from the provided input.

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