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510(k) Data Aggregation

    K Number
    K113660
    Device Name
    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
    Manufacturer
    CRYOTHERAPY PRODUCTS INC.
    Date Cleared
    2012-05-03

    (142 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL

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

    The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a device called "anucure," which is intended for the treatment of hemorrhoids by applying cold to the tissue.

    This document does not contain any information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a study report.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based solely on the provided text.

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