Clearance Summary
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) received FDA 510(k) clearance under submission number K233964, sponsored by Cosmo Artificial Intelligence - Ai, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-01-12.
- Submission: K233964
- Applicant / Sponsor: Cosmo Artificial Intelligence - Ai, Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1520
- Decision date: 2024-01-12
Classification & Regulation
This clearance is catalogued under FDA product code QNP and 21 CFR 876.1520, within the Gastroenterology, Urology review panel as a Class II device.