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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 / K253970

510(k) cleared

Wovyn Depth Electrode

Sensomedical Labs, Ltd. · Apr 17, 2026 · K253970

FDA cleared the Wovyn Depth Electrode from Sensomedical Labs, Ltd. on Apr 17, 2026 under K253970, a traditional 510(k). The device falls under product code GZL, Electrode, Depth, regulated at 21 CFR 882.1330 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 11, 2025. The decision came 127 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 Sensomedical Labs, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253970?

K253970 is the FDA 510(k) for Wovyn Depth Electrode, submitted by Sensomedical Labs, Ltd.. FDA's decision date was Apr 17, 2026, under product code GZL (Electrode, Depth).

Who makes the Wovyn Depth Electrode?

Sensomedical Labs, Ltd., based in Nazareth, is the applicant of record for K253970.

How long did the K253970 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Apr 17, 2026, 127 days later.

← All decisions in April 2026