# K250541: Self-Forming Magnet (Flexagon Plus OTOLoc)

- Pathway: 510(k) (Traditional)
- Applicant: GI Windows, Inc.
- Decided: Aug 1, 2025 after 158 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: 11 generations back to K933887 (1993). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243482: Self-Forming Magnet (Flexagon), GI Windows, Inc. (2025). Cleared while this submission was under review Summary page 6.
- K043115: Laparoscopic Compression Anastomosis Clip (Lapcac), Niti Medical Technologies, Ltd. (2004) Summary page 6.

## Most influential descendants
- K253550: Self-Forming Magnet (Flexagon Plus OTOLoc) (2026), 0 descendants of its own

## Indications for use
Flexagon Plus OTOLoc System is intended for use in the creation of side to side jejunum-jejunum and ileum-ileum 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 Flexagon Plus OTOLoc System is intended for use in adult patients > 21 years

Source page: https://510kreport.com/device/K250541
Methodology: https://510kreport.com/methodology