GIE Medical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
GIE Medical - FDA 510(k) Cleared Devices
Recent clearances: BARE Wireguided Balloon Dilation Catheter (1235)
1
Total
1
Cleared
0
Denied
GIE Medical has 1 FDA 510(k) cleared medical devices. Based in Brooklyn Park, US.
Latest FDA clearance: Mar 2026. Active since 2026. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by GIE Medical Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by RQM+ as regulatory consultant.
FDA 510(k) Regulatory Record - GIE Medical
1 devices