SAH · Class II · 21 CFR 878.4816

FDA Product Code SAH: Magnetic Compression Anastomosis System

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 Anastomosis Is Formed, The Magnet Devices Are Expelled Naturally. This Classification Does Not Include Devices Intended For Weight Loss Or Metabolic Disease Treatment

Leading manufacturers include GI Windows, Inc..

1
Total
1
Cleared
56d
Avg days
2026
Since

FDA 510(k) Cleared Magnetic Compression Anastomosis System Devices (Product Code SAH)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Magnetic Compression Anastomosis System devices (product code SAH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →