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510(k) Data Aggregation
K Number
K243359Device Name
MagDI System (MAG-02, DS-01)
Manufacturer
GT Metabolic Solutions, Inc.
Date Cleared
2025-02-28
(122 days)
Product Code
SAH
Regulation Number
878.4816Why 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
K242086Device Name
MagDI System (MAG-01, DS-01)
Manufacturer
GT Metabolic Solutions, Inc.
Date Cleared
2024-10-24
(99 days)
Product Code
SAH
Regulation Number
878.4816Why 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
DEN240013Device Name
MagDI System
Manufacturer
GT Metabolic Solutions, Inc.
Date Cleared
2024-07-02
(98 days)
Product Code
SAH
Regulation Number
878.4816Why 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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