GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US)— 510(k) K261369
Substantially EquivalentCosmo Artificial Intelligence - Ai, Ltd.
FDA 510(k) clearance K261369 for GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US), Substantially Equivalent on 2026-05-29. Applicant: Cosmo Artificial Intelligence - Ai, Ltd.. Device class: 2.
Summary
Cosmo Artificial Intelligence's record covers two items, the GI Genius Module 300 (GGM300-US) and ColonPRO US (CPRO403S-US). The record lists one product code for both: QNP, gastrointestinal lesion software detection systems.
Class II, 21 CFR 876.1520. Gastroenterology and Urology is both the classification panel and the review panel. It was a Special 510(k).
Cosmo filed from Dublin, Ireland. The decision came 32 calendar days after receipt (April 27 to May 29, 2026).
Clearance details
- Device name as filed
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
- Applicant
- Cosmo Artificial Intelligence - Ai, Ltd.
- Product code
- Product code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dublin, IE
Recent devices under product code QNP
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