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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 / December 2025 / K250863

510(k) cleared

FUJIFILM Ultrasonic Endoscope EB-710US

Fujifilm Corporation · Dec 12, 2025 · K250863

FDA cleared the FUJIFILM Ultrasonic Endoscope EB-710US from Fujifilm Corporation on Dec 12, 2025 under K250863, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Mar 21, 2025. The decision came 266 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), K260567 (EW10-EC02 Endoscopy Support Program), 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).

Questions & Answers

What did FDA clear under K250863?

K250863 is the FDA 510(k) for FUJIFILM Ultrasonic Endoscope EB-710US, submitted by Fujifilm Corporation. FDA's decision date was Dec 12, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the FUJIFILM Ultrasonic Endoscope EB-710US?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K250863.

How long did the K250863 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Dec 12, 2025, 266 days later.

← All decisions in December 2025