Cleared Traditional

K252111 - Versius Surgical System (Versius Plus) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252111 · Cmr Surgical Limited · General & Plastic Surgery device
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Dec 2025
Decision
162d
Days
Class 2
Risk

K252111 is an FDA 510(k) clearance for the Versius Surgical System (Versius Plus). Classified as Modular Electromechanical Surgical System (product code SCV), Class II - Special Controls.

Submitted by Cmr Surgical Limited (Cambridge, GB). The FDA issued a Cleared decision on December 16, 2025 after a review of 162 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4964 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cmr Surgical Limited devices

Submission Details

510(k) Number K252111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date December 16, 2025
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 114d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCV Modular Electromechanical Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4964
Definition A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Daniel & Daniel Consulting
Michael Daniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.