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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 / K260381

510(k) cleared

Eve

Wandercraft SAS · Aug 3, 2026 · K260381 · In the directory

FDA cleared the Eve from Wandercraft SAS on Aug 3, 2026 under K260381, a traditional 510(k). The device falls under product code PHL, Powered Exoskeleton, regulated at 21 CFR 890.3480 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Feb 5, 2026. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wandercraft SAS has one other decision in the tracker over the last 12 months: K250904 (Atalante X).

Questions & Answers

What did FDA clear under K260381?

K260381 is the FDA 510(k) for Eve, submitted by Wandercraft SAS. FDA's decision date was Aug 3, 2026, under product code PHL (Powered Exoskeleton).

Who makes the Eve?

Wandercraft SAS, based in Paris, is the applicant of record for K260381. The company is listed in the MedDevice Startups directory.

How long did the K260381 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Aug 3, 2026, 179 days later.

← All decisions in August 2026

Sources

In the startup directory

Wandercraft

Rehab & Mobility · Paris, France

Eve

OUR COVERAGE

Questions & Answers

What did FDA clear under K260381?

Who makes the Eve?

How long did the K260381 review take?