GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US)— 510(k) K261369

Name: FDA 510(k) clearance K261369
Creator: U.S. Food and Drug Administration
Published: 2026-05-29

Substantially Equivalent

Cosmo 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.

Clearance details

Device name as filed: GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2026-04-27
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

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K241887 — GI Genius Module 100 (GGM100.US) +4 more2024-07-25
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K231143 — GI Genius System 100 and GI Genius System 2002023-05-19
K211951 — GI Genius2021-07-23
DEN200055 — GI Genius2021-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.