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. and Gt Metabolic Solutions, Inc..
FDA 510(k) Cleared Magnetic Compression Anastomosis System Devices (Product Code SAH)
About Product Code SAH - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code SAH since 2024, with 6 receiving FDA clearance (average review time: 124 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SAH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →