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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 / December 2025 / K252111

510(k) cleared

Versius Surgical System (Versius Plus)

Cmr Surgical Limited · Dec 16, 2025 · K252111

FDA cleared the Versius Surgical System (Versius Plus) from Cmr Surgical Limited on Dec 16, 2025 under K252111, a traditional 510(k). The device falls under product code SCV, Modular Electromechanical Surgical System, regulated at 21 CFR 878.4964 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 7, 2025. The decision came 162 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 Cmr Surgical Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252111?

K252111 is the FDA 510(k) for Versius Surgical System (Versius Plus), submitted by Cmr Surgical Limited. FDA's decision date was Dec 16, 2025, under product code SCV (Modular Electromechanical Surgical System).

Who makes the Versius Surgical System (Versius Plus)?

Cmr Surgical Limited, based in Cambridge, is the applicant of record for K252111.

How long did the K252111 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Dec 16, 2025, 162 days later.

← All decisions in December 2025