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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 / August 2026 / K260567

510(k) cleared

EW10-EC02 Endoscopy Support Program

Fujifilm Corporation · Aug 7, 2026 · K260567

FDA cleared the EW10-EC02 Endoscopy Support Program from Fujifilm Corporation on Aug 7, 2026 under K260567, 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 Feb 19, 2026. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K261170 (BA-004CC), K261880 (FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01), K253137 (FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T), K254075 (Synapse Lung Nodule AI).

Questions & Answers

What did FDA clear under K260567?

K260567 is the FDA 510(k) for EW10-EC02 Endoscopy Support Program, submitted by Fujifilm Corporation. FDA's decision date was Aug 7, 2026, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the EW10-EC02 Endoscopy Support Program?

Fujifilm Corporation, based in Ashigarakami-Gun, is the applicant of record for K260567.

How long did the K260567 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Aug 7, 2026, 169 days later.

← All decisions in August 2026