GI Windows, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories1
Latest FDA decision2026-01-09
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | SAH | 2026-01-09 | View |
| 510(k) | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | SAH | 2025-08-01 | View |
| 510(k) | K243482 | Self-Forming Magnet (Flexagon) | SAH | 2025-06-11 | View |
| 510(k) | K243213 | Self-Forming Magnet (FLEX SFM) | SAH | 2025-01-29 | View |
No matching devices.
Related Clinical Trials
NCT03130244Procedure for Duodenum to Ileal Diversion to Treat Type 2 DiabetesACTIVE_NOT_RECRUITINGNCT06199635Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)COMPLETEDNCT06915337Magnet Anastomosis in Patients Undergoing Gastric SurgeryRECRUITINGNCT06915818Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing SurgeryRECRUITINGNCT07276529Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal AnastomosesRECRUITINGNCT07695558Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal AnastomosesNOT_YET_RECRUITING