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510(k) Data Aggregation

    K Number
    K243359
    Device Name
    MagDI System (MAG-02, DS-01)
    Manufacturer
    GT Metabolic Solutions, Inc.
    Date Cleared
    2025-02-28

    (122 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GT Metabolic Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21 years.
    Device Description
    The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis. After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.
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    K Number
    K242086
    Device Name
    MagDI System (MAG-01, DS-01)
    Manufacturer
    GT Metabolic Solutions, Inc.
    Date Cleared
    2024-10-24

    (99 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GT Metabolic Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GT Metabolic MagDI System is intended for use in the creation of side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21years.
    Device Description
    The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis. After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.
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    K Number
    DEN240013
    Device Name
    MagDI System
    Manufacturer
    GT Metabolic Solutions, Inc.
    Date Cleared
    2024-07-02

    (98 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GT Metabolic Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21 vears.
    Device Description
    The MagDI System is comprised of two (2) GT Metabolic DI Magnet ("Magnet") devices delivered sequentially with a minimally invasive GT Metabolic Delivery System ("Delivery System"). Class I magnetic surgical instruments (GT Metabolic Laparoscopic Positioning Device: FDA Listing #D512834) are used to position the Magnets to the target anastomosis locations in the duodenum and ileum and connect the two Magnets. The device provides a method for the creation of a round (oval/circular) compression anastomosis. After a period of approximately 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool. The MagDI System components (Magnets and Delivery System), as shown in Figures 1 and 2 below, are provided sterile and are for single use.
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