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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 / April 2026 / K260589

510(k) cleared

ES-Series

E-Scopics · Apr 29, 2026 · K260589

FDA cleared the ES-Series from E-Scopics on Apr 29, 2026 under K260589, a special 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 20, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

E-Scopics has one other decision in the tracker over the last 12 months: K260748 (ES-Series).

Questions & Answers

What did FDA clear under K260589?

K260589 is the FDA 510(k) for ES-Series, submitted by E-Scopics. FDA's decision date was Apr 29, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the ES-Series?

E-Scopics, based in Aix-En-Provence, is the applicant of record for K260589.

How long did the K260589 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Apr 29, 2026, 68 days later.

← All decisions in April 2026