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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 / K261540

510(k) cleared

Cube 4D Navigation System, VirtuEye Pro

Fiagon GmbH · Jun 2, 2026 · K261540

FDA cleared the Cube 4D Navigation System, VirtuEye Pro from Fiagon GmbH on Jun 2, 2026 under K261540, a special 510(k). The device falls under product code PGW, Ear, Nose, And Throat Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 8, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Fiagon GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261540?

K261540 is the FDA 510(k) for Cube 4D Navigation System, VirtuEye Pro, submitted by Fiagon GmbH. FDA's decision date was Jun 2, 2026, under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).

Who makes the Cube 4D Navigation System, VirtuEye Pro?

Fiagon GmbH, based in Hennigsdorf, is the applicant of record for K261540.

How long did the K261540 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jun 2, 2026, 25 days later.

← All decisions in June 2026