# K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)

- Pathway: 510(k) (Traditional)
- Applicant: Gt Metabolic Solutions, Inc.
- Decided: Jun 4, 2026 after 253 days
- Product code: SAH (Magnetic Compression Anastomosis System)
- Device class: 2
- Regulation: 21 CFR 878.4816
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN240013 (2024). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242086: MagDI System (MAG-01, DS-01), Gt Metabolic Solutions, Inc. (2024) Summary page 6.
- K243359: MagDI System (MAG-02, DS-01), Gt Metabolic Solutions, Inc. (2025) Summary page 6.

## Most influential descendants
- K261467: GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (2026), 0 descendants of its own

## Indications for use
The GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) is intended for use in the creation of side-to-side anastomoses throughout the small bowel 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 MagDITM System is intended for use in adult patients >21 years.

Source page: https://510kreport.com/device/K253102
Methodology: https://510kreport.com/methodology