GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)— 510(k) K233964

Name: FDA 510(k) clearance K233964
Creator: U.S. Food and Drug Administration
Published: 2024-01-12

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K233964 for GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US), Substantially Equivalent on 2024-01-12. Applicant: Cosmo Artificial Intelligence - Ai, Ltd.. Device class: 2.

Clearance details

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: 2023-12-15
Decision date: 2024-01-12
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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K241887 — GI Genius Module 100 (GGM100.US) +4 more2024-07-25
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K211951 — GI Genius2021-07-23
DEN200055 — GI Genius2021-04-09

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