De Novo · Granted
GrantedMagDI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gt Metabolic Solutions, Inc. · SAH Magnetic Compression Anastomosis System
Granted on Jul 2, 2024 as a new device type through De Novo after a 98-day review. 8 later devices descend from it.
- Decided
- Jul 2, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
8 later devices descend from it, 2 citing it directly.
- This deviceDEN240013 MagDI SystemGt Metabolic Solutions, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK243213 Self-Forming Magnet (FLEX SFM)GI Windows, Inc. · 2025
- Descendant · cites it directly · 3 of its ownK242086 MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK243482 Self-Forming Magnet (Flexagon)GI Windows, Inc. · 2025
- Descendant · 2 generations on · 2 of its ownK243359 MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK253102 GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K243213Self-Forming Magnet (FLEX SFM)GI Windows, Inc. · 2025 · cites it directly3descendants
- K242086MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. · 2024 · cites it directly3descendants
- K243482Self-Forming Magnet (Flexagon)GI Windows, Inc. · 2025 · 2 generations on2descendants
- K243359MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2025 · 2 generations on2descendants
- K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2026 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024 | — |
| +1 | K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | 2025 | — |
| +1 | K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024 | — |
| +2 | K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025 | — |
| +2 | K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025 | — |
| +2 | K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAH device
- #1 K242086 MagDI System (MAG-01, DS-01)score 17.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243213 (GI Windows, Inc., 2025) has gone furthest, with 3 descendants of its own.
How does its category compare?
All SAH devicesSAH Magnetic Compression Anastomosis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAH
140in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SAH
No recall names SAH since 2007.
Adverse event reports per year · SAH
No MAUDE report names SAH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 4 | 140 | 0 | 0 |
| 2026 | 3 | 135 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240013 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240013: MagDI System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240013
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026