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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 / K253607

510(k) cleared

UNEEG EpiSight System

Uneeg Medical A/S · Jun 11, 2026 · K253607

FDA cleared the UNEEG EpiSight System from Uneeg Medical A/S on Jun 11, 2026 under K253607, a traditional 510(k). The device falls under product code SEM, Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring, regulated at 21 CFR 882.1360 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 18, 2025. The decision came 205 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Uneeg Medical A/S in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253607?

K253607 is the FDA 510(k) for UNEEG EpiSight System, submitted by Uneeg Medical A/S. FDA's decision date was Jun 11, 2026, under product code SEM (Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring).

Who makes the UNEEG EpiSight System?

Uneeg Medical A/S, based in Alleroed, is the applicant of record for K253607.

How long did the K253607 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Jun 11, 2026, 205 days later.

← All decisions in June 2026