Data / Medical devices / United States / GT Metabolic Solutions, Inc.
GT Metabolic Solutions, Inc.: FDA-registered device maker in Saint Michael, MN, United States, 3 510(k) clearances
GT Metabolic Solutions, Inc. is registered with the FDA (registration 3017462289) in Saint Michael, MN, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017462289
- Address
- 5450 Quam Ave NE, Suite 100, Saint Michael, MN, United States, 55376
- Owner or operator
- GT Metabolic Solutions, Inc. (10088645)
- Roles
- Manufacturer
- First device listed
- September 14, 2023
- Registered through
- 2027
- Brand names listed
- GT Metabolic Instrument Set, GT Metabolic Laparoscopic Positioning Device, GT Metabolic MagDI System, 40mm, GT Metabolic MagDI System, 50mm, GT Metabolic Magnet System (MAG-04, DS-01); GT Metabolic Magnet System (MAG-05, DS-01), GT Metabolic Magnetic Retrieval Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Magnetic Retriever, Exempt | PTQ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Magnetic Compression Anastomosis System | SAH | 2 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | SAH | Substantially Equivalent | Gt Metabolic Solutions, Inc. | accessdata.fda.gov |
| February 28, 2025 | K243359 | MagDI System (MAG-02, DS-01) | SAH | Substantially Equivalent | Gt Metabolic Solutions, Inc. | accessdata.fda.gov |
| October 24, 2024 | K242086 | MagDI System (MAG-01, DS-01) | SAH | Substantially Equivalent | Gt Metabolic Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Endoscopic Magnetic Retriever, Exempt
- All makers of Instrument, Manual, Surgical, General Use
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.