DEN230032 is an FDA 510(k) submission for the Symani Surgical System. This device is classified as a Electromechanical System For Open Microsurgery (Class II - Special Controls, product code SAQ).
Submitted by Mmi North America, Inc. (Ponte Vedra, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4963. An Electromechanical System For Open Microsurgery Is A Software-controlled Electromechanical System With Bedside Human/device Interfaces And Without An Integrated Visualization System Which Allows A Qualified User To Perform Surgical Techniques During Open Mircosurgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm..
| 510(k) Number | DEN230032 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 25, 2023 |
| Decision Date | April 05, 2024 |
| Days to Decision | 346 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | SAQ - Electromechanical System For Open Microsurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4963 |
| Definition | An Electromechanical System For Open Microsurgery Is A Software-controlled Electromechanical System With Bedside Human/device Interfaces And Without An Integrated Visualization System Which Allows A Qualified User To Perform Surgical Techniques During Open Mircosurgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm. |