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 Gt Metabolic Solutions, Inc. and GI Windows, Inc..

8
Total
7
Cleared
140d
Avg days
2024
Since
Growing category - 7 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 146d recently vs 98d historically

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

8 devices
1–8 of 8
Cleared Jun 04, 2026
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
K253102
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 253d
Cleared Jan 09, 2026
Self-Forming Magnet (Flexagon Plus OTOLoc)
K253550
GI Windows, Inc.
General & Plastic Surgery · 56d
Cleared Aug 01, 2025
Self-Forming Magnet (Flexagon Plus OTOLoc)
K250541
GI Windows, Inc.
General & Plastic Surgery · 158d
Cleared Jun 11, 2025
Self-Forming Magnet (Flexagon)
K243482
GI Windows, Inc.
General & Plastic Surgery · 215d
Cleared Feb 28, 2025
MagDI System (MAG-02, DS-01)
K243359
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 122d
Cleared Jan 29, 2025
Self-Forming Magnet (FLEX SFM)
K243213
GI Windows, Inc.
General & Plastic Surgery · 118d
Cleared Oct 24, 2024
MagDI System (MAG-01, DS-01)
K242086
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 99d
Not Cleared Jul 02, 2024
MagDI System
DEN240013
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 98d

About Product Code SAH - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code SAH since 2024, with 7 receiving FDA clearance (average review time: 140 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - SAH Product Code

Recent submissions under SAH have taken an average of 146 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.

SAH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →