510(k) K243213
- Device
- Self-Forming Magnet (FLEX SFM)
- Applicant
- GI Windows, Inc.
- 510(k) number
- K243213
- Product code
- SAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-29
- Date received
- 2024-10-03
- Regulation
- 878.4816
- Classification name
- Magnetic Compression Anastomosis System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yverre Bobay
- Address
- 380 University Ave. Westwood MA US 02090 02090
FDA Registration Numbers#
- 1450662
- 3017462289
- 3021969326
Source Documents#
Other 510(k) Records For Product Code SAH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026-01-09 |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025-08-01 |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025-06-11 |
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025-02-28 |
| K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024-10-24 |
| DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024-07-02 |