Not Cleared Direct

DEN230078 - Versius Surgical System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230078 · Cmr Surgical Limited · General & Plastic Surgery device
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Oct 2024
Decision
325d
Days
Class 2
Risk

DEN230078 is an FDA 510(k) submission (not cleared) for the Versius Surgical System. Classified as Modular Electromechanical Surgical System (product code SCV), Class II - Special Controls.

Submitted by Cmr Surgical Limited (Cambridge, GB). The FDA issued a Not Cleared (DENG) decision on October 11, 2024 after a review of 325 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 325 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Cmr Surgical Limited devices

Submission Details

510(k) Number DEN230078 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 21, 2023
Decision Date October 11, 2024
Days to Decision 325 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 114d · This submission: 325d
Pathway characteristics

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.