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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 / June 2026 / K253137

510(k) cleared

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

Fujifilm Corporation · Jun 16, 2026 · K253137

FDA cleared the FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T from Fujifilm Corporation on Jun 16, 2026 under K253137, 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 Sep 25, 2025. The decision came 264 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), K254075 (Synapse Lung Nodule AI).

Questions & Answers

What did FDA clear under K253137?

K253137 is the FDA 510(k) for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T, submitted by Fujifilm Corporation. FDA's decision date was Jun 16, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K253137.

How long did the K253137 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 16, 2026, 264 days later.

← All decisions in June 2026