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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 / K260976

510(k) cleared

NeuroBlate System

Monteris Medical · Apr 23, 2026 · K260976

FDA cleared the NeuroBlate System from Monteris Medical on Apr 23, 2026 under K260976, a special 510(k). The device falls under product code ONO, Neurosurgical Laser With Mr Thermography, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 24, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260976?

K260976 is the FDA 510(k) for NeuroBlate System, submitted by Monteris Medical. FDA's decision date was Apr 23, 2026, under product code ONO (Neurosurgical Laser With Mr Thermography).

Who makes the NeuroBlate System?

Monteris Medical, based in Minnetonka, MN, is the applicant of record for K260976.

How long did the K260976 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on Apr 23, 2026, 30 days later.

← All decisions in April 2026