DEN240013 is an FDA 510(k) submission for the MagDI System. This device is classified as a Magnetic Compression Anastomosis System (Class II - Special Controls, product code SAH).
Submitted by Gt Metabolic Solutions, Inc. (San Jose, US). The FDA issued a Not Cleared (DENG) decision on July 2, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4816. 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.
| 510(k) Number | DEN240013 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 26, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 98 days |
| Submission Type | Post-NSE |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | SAH - Magnetic Compression Anastomosis System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4816 |
| Definition | 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 |