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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 / K261833

510(k) cleared

NEUROMARK System (NMK00301)

Neurent Medical , Ltd. · Jun 16, 2026 · K261833 · In the directory

FDA cleared the NEUROMARK System (NMK00301) from Neurent Medical , Ltd. on Jun 16, 2026 under K261833, a special 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 2, 2026. The decision came 14 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Neurent Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261833?

K261833 is the FDA 510(k) for NEUROMARK System (NMK00301), submitted by Neurent Medical , Ltd.. FDA's decision date was Jun 16, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the NEUROMARK System (NMK00301)?

Neurent Medical , Ltd., based in Galway, is the applicant of record for K261833. The company is listed in the MedDevice Startups directory.

How long did the K261833 review take?

FDA received the submission on Jun 2, 2026 and issued its decision on Jun 16, 2026, 14 days later.

← All decisions in June 2026

Sources

In the startup directory

Neurent Medical

Respiratory & Sleep · Galway, Ireland