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510(k) Data Aggregation

    K Number
    K042527
    Device Name
    SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Date Cleared
    2004-11-08

    (52 days)

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

    SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107

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

    For use as a diagnostic accessory. A blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.

    Device Description

    Cervical Scraper

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a Cervical Scraper (K042527). It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot fulfill the request to describe acceptance criteria and associated studies from the provided text. The document primarily focuses on regulatory approval and indications for use.

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