K261369
- 510(k) number
- K261369
- Device name
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
- Applicant
- Cosmo Artificial Intelligence - Ai, Ltd. IE
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2026-05-29
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261369.pdf
Official FDA record: K261369
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.