DEN230025 is an FDA 510(k) submission for the MIRA Surgical System. This device is classified as a Table Mounted Miniaturized Electromechanical Surgical System (Class II - Special Controls, product code SAB).
Submitted by Virtual Incision (Lincoln, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4962. A Table Mounted Miniaturized Electromechanical Surgical System Is A Software-controlled Electromechanical System With Surgical Table Mounted Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures Where The Software-controlled Electromechanical Devices Miniaturized And Compact Size Allows The Effective Element Of The System To Be Inserted Into The Body Cavity And Use Surgical Instruments Attached To The Electromechanical Arms.
| 510(k) Number | DEN230025 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 11, 2023 |
| Decision Date | February 23, 2024 |
| Days to Decision | 318 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | SAB - Table Mounted Miniaturized Electromechanical Surgical System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4962 |
| Definition | A Table Mounted Miniaturized Electromechanical Surgical System Is A Software-controlled Electromechanical System With Surgical Table Mounted Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures Where The Software-controlled Electromechanical Devices Miniaturized And Compact Size Allows The Effective Element Of The System To Be Inserted Into The Body Cavity And Use Surgical Instruments Attached To The Electromechanical Arms |