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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 / August 2026 / K260563

510(k) cleared

CN-Suite

FIND Surgical Sciences Inc. D/B/A FIND Neuro · Aug 16, 2026 · K260563

FDA cleared the CN-Suite from FIND Surgical Sciences Inc. D/B/A FIND Neuro on Aug 16, 2026 under K260563, a traditional 510(k). The device falls under product code OLX, Source Localization Software For Electroencephalograph Or Magnetoencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 19, 2026. The decision came 178 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 FIND Surgical Sciences Inc. D/B/A FIND Neuro in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260563?

K260563 is the FDA 510(k) for CN-Suite, submitted by FIND Surgical Sciences Inc. D/B/A FIND Neuro. FDA's decision date was Aug 16, 2026, under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph).

Who makes the CN-Suite?

FIND Surgical Sciences Inc. D/B/A FIND Neuro, based in Cambridge, MA, is the applicant of record for K260563.

How long did the K260563 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Aug 16, 2026, 178 days later.

← All decisions in August 2026