GI Genius Module 100 (GGM100.US) +4 more— 510(k) K241887

Name: FDA 510(k) clearance K241887
Creator: U.S. Food and Drug Administration
Published: 2024-07-25

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K241887 for GI Genius Module 100 (GGM100.US) +4 more, Substantially Equivalent on 2024-07-25. Applicant: Cosmo Artificial Intelligence - Ai, Ltd.. Device class: 2.

Clearance details

Device name as filed: 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)
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: 2024-06-28
Decision date: 2024-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

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K261369 — GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US)2026-05-29
K260724 — MAGENTIQ-COLO (ME-APDS)2026-04-03

More clearances from Cosmo Artificial Intelligence - Ai, Ltd.

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K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)2024-01-12
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.