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FDA 510(k)

Versius Surgical System (Versius Plus)

K-Number: K252111 · 2025-12-16

ApplicantCmr Surgical Limited
Decision Date2025-12-16
Product CodeSCV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Versius Surgical System (Versius Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Cmr Surgical Limited. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252111. The device is classified under product code SCV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Versius Surgical System (Versius Plus)?

Versius Surgical System (Versius Plus) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Cmr Surgical Limited. The 510(k) number is K252111.

When did Versius Surgical System (Versius Plus) receive FDA 510(k) clearance?

Versius Surgical System (Versius Plus) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252111.

Who is the listed applicant for Versius Surgical System (Versius Plus)?

The FDA 510(k) record lists Cmr Surgical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Versius Surgical System (Versius Plus)?

The FDA product code for Versius Surgical System (Versius Plus) is SCV.

Related Devices (Code: SCV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260804Anovo Surgical System (6Ne)Momentis Surgical , Ltd.K250725Hugo™ RAS SystemCovidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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