BARE Wireguided Balloon Dilation Catheter (1235)
Mar 2026
91d
GIE Medical
1
Total
1
Cleared
0
Denied
GIE Medical — FDA 510(k) Submissions
GIE Medical has submitted 1 FDA 510(k) premarket notifications since 2026, of which 1 received clearance as substantially equivalent to a predicate device.
The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts . Use the specialty filter in the sidebar to narrow results.
1 devices