Self-Forming Magnet (FLEX SFM)
FDA 510(k) clearance K243213 · decided 2025-01-29
Clearance details
- K-number
- K243213
- Device name
- Self-Forming Magnet (FLEX SFM)
- Applicant
- GI Windows, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-03
- Decision date
- 2025-01-29
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- SAH
- Device class
- 2
- Regulation number
- 878.4816
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (K253102) | Gt Metabolic Solutions, Inc. | 2026-06-04 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K253550) | GI Windows, Inc. | 2026-01-09 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541) | GI Windows, Inc. | 2025-08-01 |
| Self-Forming Magnet (Flexagon) (K243482) | GI Windows, Inc. | 2025-06-11 |
| MagDI System (MAG-02, DS-01) (K243359) | Gt Metabolic Solutions, Inc. | 2025-02-28 |
| MagDI System (MAG-01, DS-01) (K242086) | Gt Metabolic Solutions, Inc. | 2024-10-24 |
| MagDI System (DEN240013) | Gt Metabolic Solutions, Inc. | 2024-07-02 |
Recalls involving this device
No recalls on record reference this clearance.