FDA product code · General and plastic surgery
Magnetic Compression Anastomosis System
9 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 122 days (half between 118 and 158). No recall names this code. The most-cited predicate is K242086, named by 3 later devices.
A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SAH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in SAH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report