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510(k) Data Aggregation

    K Number
    K020628
    Device Name
    CURELLE, PREFERRED CURELLE, CUTEQ 2.5
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2002-05-24

    (87 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CURELLE, PREFERRED CURELLE, CUTEQ 2.5

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

    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.

    Device Description

    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5

    AI/ML Overview

    I am sorry, but the provided text only contains regulatory information about FDA clearance for endometrial suction curettes. It does not include any details about acceptance criteria, study designs, performance data, or ground truth establishment for a medical device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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