FDA AI Clearance Tracker/K261369
Gastroenterology-Urology · 510(k)
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
Cosmo Artificial Intelligence - Ai, Ltd.
- Device
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
- Company
- Cosmo Artificial Intelligence - Ai, Ltd.
- Submission number
- K261369
- Pathway
- 510(k)
- Decision date
- May 29, 2026
- Specialty (lead panel)
- Gastroenterology-Urology
- Primary product code
- QNP
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.