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Cosmo Artificial Intelligence - Ai, Ltd. FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)510(k)May 29, 2026Gastroenterology, Urology |
| GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)510(k)Jul 25, 2024Gastroenterology, Urology |
| GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)510(k)Jan 12, 2024Gastroenterology, Urology |
| GI Genius System 100 and GI Genius System 200510(k)May 19, 2023Gastroenterology, Urology |
| GI Genius510(k)Jul 23, 2021Gastroenterology, Urology |
| GI Genius510(k)Apr 9, 2021Gastroenterology, Urology |