FDA Product Code
FDA Product Code SAH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4816
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | 2026-09-16 | Traditional | PDF ↗ |
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2026-06-04 | Traditional | PDF ↗ |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026-01-09 | Traditional | PDF ↗ |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025-06-11 | Traditional | PDF ↗ |
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025-02-28 | Traditional | PDF ↗ |
| K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | 2025-01-29 | Traditional | PDF ↗ |
| K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024-10-24 | Traditional | PDF ↗ |
| DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024-07-02 | Post-NSE | — |
Product code SAH · Class II · General, Plastic Surgery. Data: openFDA.