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THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261252

510(k) cleared

Versius Surgical System (Versius Plus)

Cmr Surgical Limited · Oct 21, 2026 · K261252 · In the directory

FDA cleared the Versius Surgical System (Versius Plus) from Cmr Surgical Limited on Oct 21, 2026 under K261252, 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 Apr 16, 2026. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cmr Surgical Limited has one other decision in the tracker over the last 12 months: K252111 (Versius Surgical System (Versius Plus)).

Questions & Answers

What did FDA clear under K261252?

K261252 is the FDA 510(k) for Versius Surgical System (Versius Plus), submitted by Cmr Surgical Limited. FDA's decision date was Oct 21, 2026, 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 K261252. The company is listed in the MedDevice Startups directory.

How long did the K261252 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Oct 21, 2026, 188 days later.

← All decisions in October 2026

Sources

In the startup directory

CMR Surgical

Surgical & Robotics · Cambridge, UK