LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070124
    Device Name
    GASTROSTOMY REPLACEMENT TUBE, MODEL 253
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2007-05-23

    (127 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 :

    GASTROSTOMY REPLACEMENT TUBE, MODEL 253

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

    Gastrostomy Replacement Tube of Degania Silicone Ltd is indicated for 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

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Gastrostomy Replacement Tube and does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1