510(k) · Cleared
ClearedSelf-Forming Magnet (Flexagon Plus OTOLoc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GI Windows, Inc. · SAH Magnetic Compression Anastomosis System
Cleared on Aug 1, 2025 as substantially equivalent to K243482 (GI Windows, Inc., 2025) and 1 other predicate after a 158-day review. Its family tree reaches back 11 generations to 1993. 1 later device descends from it.
- Decided
- Aug 1, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K933887 (1993). 41 ancestors in all, the oldest K771412 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 7 generations between
- 3 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- This deviceK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253550 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 10 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 9 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 8 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 7 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 6 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 5 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 4 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 3 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- This deviceK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −10 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −9 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −8 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −7 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −6 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −5 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −4 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −3 | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −2 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −1 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| 0 (this device) | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| +1 | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243482 | Self-Forming Magnet (Flexagon) Cleared while this submission was under review Summary page 6…duct Codes: SAH Primary Predicate Device: Device Trade Name: Self-Forming Magnet (FLEXAGON) Common Name: Self-Forming Magnet System Submission Number: K243482 Classification Name: Magnetic Compression Anastomosis System Regulation Number: 878.4816 Product Codes: SAH Seco… | 2025 |
| * | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac)Summary page 6…Codes: SAH Secondary Predicate Device: Device Trade Name: NiTi Medical Technologies, Ltd. Laparoscopic Compression Anastomosis Clip (CAC) Submission Number: K043115 Classification Name: Clip, implantable Regulation Number: 878.4300 Product Codes: FZP Reference Device:… | 2004 |
| † | K913411 | Davis & Geck Valtrac (R) Biofrag Anastomosis Ring | 1991 |
| † | K931056 | Davis+Geck Valtrac Biofrag Anastomosis Ring | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | 2026 | 0 |
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 5 of the 41 ancestors have a recall of any class.
- Of its descendants, K253550 (GI Windows, Inc., 2026) has gone furthest, with 0 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. 2025, 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?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250541: Self-Forming Magnet (Flexagon Plus OTOLoc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250541
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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