Cleared Traditional

K261252 - Versius Surgical System (Versius Plus)

K261252 is an FDA 510(k) clearance for Versius Surgical System (Versius Plus), manufactured by Cmr Surgical Limited. The device is a Class 2 General & Plastic Surgery device with product code SCV cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K261252 · Cmr Surgical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
188d
Days
Class 2
Risk

K261252 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 October 21, 2026 after a review of 188 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.

FDA 510(k) Submission Details - K261252

510(k) Number K261252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date October 21, 2026
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SCV Device Classification - Class 2, Special Controls

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.

K261252 · Versius Surgical System (Versius Plus)
Download PDF FDA Summary Cmr Surgical Limited