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510(k) Data Aggregation

    K Number
    K012476
    Device Name
    MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2001-08-31

    (29 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Monarch™ Transshaping Gastrostomy Tube is to be used as a percutaneous replacement gastrostomy tube for a patient with a well-established gastrostomy tract. This device will assist in providing nutrition by connection of an established stoma in a patient who is unable to consume nutrition by other means and allow for decompression of the stomach.

    Device Description

    Monarch™ Transshaping Gastrostomy Tube

    AI/ML Overview

    I am sorry. I cannot provide the information in the requested format based on the given input. The provided text is a regulatory clearance letter from the FDA (K012476 for the Monarch™ Transshaping Gastrostomy Tube), which does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The document primarily focuses on:

    • Confirming substantial equivalence to a predicate device.
    • Outlining regulatory compliance requirements (GMP, labeling, etc.).
    • Listing the indications for use.

    Therefore, I cannot fulfill your request for details on the device's acceptance criteria and the study proving it meets those criteria.

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