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510(k) Data Aggregation

    K Number
    K122030
    Device Name
    LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2012-09-05

    (56 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON

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

    Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Degania Silicone Gastrostomy Button. It is not a study report and therefore does not contain the information requested in your prompt regarding acceptance criteria and performance data for a device.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device but does not provide any details about performance criteria, study design, or results.

    To answer your questions, I would need access to the actual 510(k) submission (K122030) or a separate study report for the Degania Silicone Gastrostomy Button.

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