Gi View , Ltd. is one of 16358 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gi View , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Solo Scope Colonoscope System, Aer-O-Scope Colonoscope System, Aer-O-Scope Colonoscope System
4
Total
4
Cleared
0
Denied
Gi View , Ltd. has 4 FDA 510(k) cleared medical devices. Based in Washington, US.
Latest FDA clearance: Aug 2026. Active since 2014. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Gi View , Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Goodwin Procter Llp, Covington & Burling, Llp and A. Stein - Regulatory Affairs Consulting , Ltd..
FDA 510(k) Regulatory Record - Gi View , Ltd.
4 devices
Cleared
Aug 21, 2026
Solo Scope Colonoscope System
Gastroenterology & Urology
147d
Cleared
Aug 17, 2023
Aer-O-Scope Colonoscope System
Gastroenterology & Urology
168d
Cleared
Aug 11, 2016
Aer-O-Scope Colonoscope System
Gastroenterology & Urology
43d
Cleared
Sep 30, 2014
AER-O-SCOPE COLONOSCOPE SYSTEM
Gastroenterology & Urology
137d