Gt Metabolic Solutions, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Gt Metabolic Solutions, Inc.” (first 2024, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 128 days. Since 2017 the median was 128 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 99 |
| 2025 | 1 | 122 |
| 2026 | 2 | 194 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gt Metabolic Solutions, Inc. took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAH | Magnetic Compression Anastomosis System | 5 | 4 |
Review panels
Most recent Gt Metabolic Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | SAH | 2026-09-16 | 135 |
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | SAH | 2026-06-04 | 253 |
| K243359 | MagDI System (MAG-02, DS-01) | SAH | 2025-02-28 | 122 |
| K242086 | MagDI System (MAG-01, DS-01) | SAH | 2024-10-24 | 99 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240013 | De Novo | Magnetic Compression Anastomosis System | 2024-07-02 |
Recalls
openFDA lists no recalls under a recalling firm named Gt Metabolic Solutions, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Gt Metabolic Solutions, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (8 active or recruiting). Most recent:
- NCT07317115: Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (Recruiting, started 2026-03-18)
- NCT07431723: Creation of Compression Anastomosis Using the GT Metabolic Magnet System (Recruiting, started 2026-02-16)
- NCT07317076: GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (Recruiting, started 2025-12-09)
- NCT07085741: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico (Active not recruiting, started 2025-05-07)
- NCT06928545: MagDI U.S. Registry (Recruiting, started 2025-03-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gt Metabolic Solutions, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Gt Metabolic Solutions, Inc.” (first 2024, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gt Metabolic Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gt Metabolic Solutions, Inc. is 128 days. Since 2017: 128 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gt Metabolic Solutions, Inc.?
The most frequent FDA product codes under this applicant name are SAH (Magnetic Compression Anastomosis System, 5).
Next steps
- See all 4 Gt Metabolic Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAH, Gt Metabolic Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.