# DEN240013: MagDI System

- Pathway: De Novo (Post-NSE)
- Applicant: Gt Metabolic Solutions, Inc.
- Decided: Jul 2, 2024 after 98 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243213: Self-Forming Magnet (FLEX SFM) (2025), 3 descendants of its own
- K242086: MagDI System (MAG-01, DS-01) (2024), 3 descendants of its own
- K243482: Self-Forming Magnet (Flexagon) (2025), 2 descendants of its own
- K243359: MagDI System (MAG-02, DS-01) (2025), 2 descendants of its own
- K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (2026), 1 descendant of its own

## Indications for 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.

Source page: https://510kreport.com/device/DEN240013
Methodology: https://510kreport.com/methodology