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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 / February 2026 / K250550

510(k) cleared

FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

Fujifilm Corporation · Feb 17, 2026 · K250550

FDA cleared the FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit from Fujifilm Corporation on Feb 17, 2026 under K250550, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 25, 2025. The decision came 357 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 K250550?

K250550 is the FDA 510(k) for FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit, submitted by Fujifilm Corporation. FDA's decision date was Feb 17, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K250550.

How long did the K250550 review take?

FDA received the submission on Feb 25, 2025 and issued its decision on Feb 17, 2026, 357 days later.

← All decisions in February 2026