LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983202
    Device Name
    HARWILL MEDICAL CERVITULA CERVICAL SPATULA
    Manufacturer
    HARWILL MEDICAL (PTY) LTD.
    Date Cleared
    1999-03-15

    (182 days)

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

    The Harwill Medical Cervitula is a disposable cervical spatula that is used to collect endo and ectocervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Harwill Medical Cervitula is not intended for use in pregnant women.

    Device Description

    The Harwill Medical Cervitula is a disposable cervical spatula.

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance for a medical device (Harwill Medical Cervitula Cervical Spatula) and does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for an AI/algorithm-based device.

    Therefore, I cannot fulfill the request as the necessary information is not present in the given text. This document is a regulatory approval letter and indications for use, not a detailed study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1