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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K261369

510(k) cleared

GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)

Cosmo Artificial Intelligence - Ai, Ltd. · May 29, 2026 · K261369

FDA cleared the GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) from Cosmo Artificial Intelligence - Ai, Ltd. on May 29, 2026 under K261369, a special 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 27, 2026. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cosmo Artificial Intelligence - Ai, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261369?

K261369 is the FDA 510(k) for GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US), submitted by Cosmo Artificial Intelligence - Ai, Ltd.. FDA's decision date was May 29, 2026, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)?

Cosmo Artificial Intelligence - Ai, Ltd., based in Dublin, is the applicant of record for K261369.

How long did the K261369 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on May 29, 2026, 32 days later.

← All decisions in May 2026