Medical Device Manufacturer · US , Brooklyn Park , MN

GIE Medical - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

Recent clearances: BARE Wireguided Balloon Dilation Catheter (1235)

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - GIE Medical Gastroenterology & Urology ✕

1 devices

1-1 of 1

Cleared Mar 13, 2026

BARE Wireguided Balloon Dilation Catheter (1235)

Gastroenterology & Urology · 91d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Apr 27, 2026