Cosmo Artificial Intelligence - Ai, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: GI Genius™ Module 300 (GGM300-US), GI Genius™ Module 100 (GGM100.US), GI Genius™ Module 100 (GGM100.US)
6
Total
5
Cleared
1
Denied
FDA 510(k) Regulatory Record - Cosmo Artificial Intelligence - Ai, Ltd. Gastroenterology & Urology ✕
6 devices
Cleared
May 29, 2026
GI Genius™ Module 300 (GGM300-US)
Gastroenterology & Urology
32d
Cleared
Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
Gastroenterology & Urology
27d
Cleared
Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
Gastroenterology & Urology
28d
Cleared
May 19, 2023
GI Genius System 100 and GI Genius System 200
Gastroenterology & Urology
28d
Cleared
Jul 23, 2021
GI Genius
Gastroenterology & Urology
30d
Not Cleared
Apr 09, 2021
GI Genius
Gastroenterology & Urology
213d