DEN230078 is an FDA 510(k) submission for the Versius Surgical System. This device is classified as a Modular Electromechanical Surgical System (Class II - Special Controls, product code SCV).
Submitted by Cmr Surgical Limited (Cambridge, GB). The FDA issued a Not Cleared (DENG) decision on October 11, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4964. 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..
| 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 | - |
| Product Code | SCV - Modular Electromechanical Surgical System |
| Device Class | Class II - 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. |