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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 / February 2026 / K253536

510(k) cleared

Evala Nerve Stimulator (EPNR002)

Epineuron Technologies, Inc. · Feb 27, 2026 · K253536

FDA cleared the Evala Nerve Stimulator (EPNR002) from Epineuron Technologies, Inc. on Feb 27, 2026 under K253536, a traditional 510(k). The device falls under product code ETN, Stimulator, Nerve, regulated at 21 CFR 874.1820 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Nov 13, 2025. The decision came 106 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 Epineuron Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253536?

K253536 is the FDA 510(k) for Evala Nerve Stimulator (EPNR002), submitted by Epineuron Technologies, Inc.. FDA's decision date was Feb 27, 2026, under product code ETN (Stimulator, Nerve).

Who makes the Evala Nerve Stimulator (EPNR002)?

Epineuron Technologies, Inc., based in Mississauga, is the applicant of record for K253536.

How long did the K253536 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Feb 27, 2026, 106 days later.

← All decisions in February 2026