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 Jan 9, 2026 as substantially equivalent to K250541 (GI Windows, Inc., 2025) after a 56-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Jan 9, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K933887 (1993). 42 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 12 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 8 generations between
- 3 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- This deviceK253550 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 11 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 10 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 9 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 8 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 7 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 6 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 5 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 4 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 3 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- This deviceK253550 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −11 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −10 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −9 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −8 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −7 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −6 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −5 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −4 | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −3 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −2 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −1 | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc)Summary page 5…s: SAH Primary Predicate Device: Device Trade Name: GI Windows’ Flexagon Plus OTOLoc System Common Name: Self-Forming Magnet System Submission Number: K250541 Classification Name: Magnetic Compression Anastomosis System Regulation Number: 878.4816 Product Codes: SAH Limi… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 5 of the 42 ancestors have a recall of any class.
How does its category compare?
All SAH devicesSAH Magnetic Compression Anastomosis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of a 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 GI Windows 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/K253550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253550: Self-Forming Magnet (Flexagon Plus OTOLoc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253550
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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