# K243213: Self-Forming Magnet (FLEX SFM)

- Pathway: 510(k) (Traditional)
- Applicant: GI Windows, Inc.
- Decided: Jan 29, 2025 after 118 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: 1 generation back to DEN240013 (2024). 1 ancestor in all.
3 later devices descend 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)
- DEN240013: MagDI System, Gt Metabolic Solutions, Inc. (2024) Summary page 6.

## Most influential descendants
- K243482: Self-Forming Magnet (Flexagon) (2025), 2 descendants of its own
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc) (2025), 1 descendant of its own
- K253550: Self-Forming Magnet (Flexagon Plus OTOLoc) (2026), 0 descendants of its own

## Indications for use
The GI Windows FLEX SFM 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 GI Windows FLEX SFM is intended for use in adult patients > 21 years.

Source page: https://510kreport.com/device/K243213
Methodology: https://510kreport.com/methodology