FDA 510(k) K243213, Self-Forming Magnet (FLEX SFM), by GI Windows, Inc.
FDA 510(k) K243213, Self-Forming Magnet (FLEX SFM), by GI Windows, Inc.
| 510(k) Number | K243213 |
| Device Classification Name | Magnetic Compression Anastomosis System |
| Device Name | Self-Forming Magnet (FLEX SFM) |
| Applicant | GI Windows, Inc. 380 University Ave. Westwood, MA 02090 |
| Classification Product Code | SAH |
| Date Received | 10/03/2024 |
| Decision Date | 01/29/2025 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 5262 |
| Redacted Pages | 4725 |
| Unredacted Pages | 537 |
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