K243213 is an FDA 510(k) clearance for the Self-Forming Magnet (FLEX SFM). This device is classified as a Magnetic Compression Anastomosis System (Class II - Special Controls, product code SAH).
Submitted by GI Windows, Inc. (Westwood, US). The FDA issued a Cleared decision on January 29, 2025, 118 days after receiving the submission on October 3, 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 | K243213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2024 |
| Decision Date | January 29, 2025 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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 |