FDA 510(k) K242086, MagDI System (MAG-01, DS-01), by Gt Metabolic Solutions, Inc.
FDA 510(k) K242086, MagDI System (MAG-01, DS-01), by Gt Metabolic Solutions, Inc.
| 510(k) Number | K242086 |
| Device Classification Name | Magnetic Compression Anastomosis System |
| Device Name | MagDI System (MAG-01, DS-01) |
| Applicant | Gt Metabolic Solutions, Inc. 3050 Three Springs Ct. San Jose, CA 95140 |
| Classification Product Code | SAH |
| Date Received | 07/17/2024 |
| Decision Date | 10/24/2024 |
| 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 | 2465 |
| Redacted Pages | 1998 |
| Unredacted Pages | 467 |
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