GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)— 510(k) K261467
Substantially EquivalentGt Metabolic Solutions, Inc.
FDA 510(k) clearance K261467 for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01), Substantially Equivalent on 2026-09-16. Applicant: Gt Metabolic Solutions, Inc.. Device class: 2.
Summary
GT Metabolic Magnet System is from Gt Metabolic Solutions, Inc., filed under product code SAH (Magnetic Compression Anastomosis System). The device name lists two configurations, MAG-04 with DS-01 and MAG-05 with DS-01, run together without a separator in the record.
Class II, 21 CFR 878.4816. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
GT Metabolic filed from St. Michael, Minnesota. The decision came 135 calendar days after FDA received it (May 4 to September 16, 2026).
Clearance details
- Applicant
- Gt Metabolic Solutions, Inc.
- Product code
- Product code SAH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4816
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Michael, MN, US
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