Medical Device Manufacturer · US , Westwood , MA

GI Windows, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2025

Recent clearances: Self-Forming Magnet (Flexagon Plus OTOLoc), Self-Forming Magnet (Flexagon Plus OTOLoc), Self-Forming Magnet (Flexagon)

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - GI Windows, Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Jan 09, 2026

Self-Forming Magnet (Flexagon Plus OTOLoc)

General & Plastic Surgery · 56d

Cleared Aug 01, 2025

Self-Forming Magnet (Flexagon Plus OTOLoc)

General & Plastic Surgery · 158d

Cleared Jun 11, 2025

Self-Forming Magnet (Flexagon)

General & Plastic Surgery · 215d

Cleared Jan 29, 2025

Self-Forming Magnet (FLEX SFM)

General & Plastic Surgery · 118d