K250014 is an FDA 510(k) clearance for the Symani Surgical System (820-03830). This device is classified as a Electromechanical System For Open Microsurgery (Class II - Special Controls, product code SAQ).
Submitted by Medical Microinstruments, Inc. (Pisa, IT). The FDA issued a Cleared decision on January 27, 2025, 25 days after receiving the submission on January 2, 2025.
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 | K250014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2025 |
| Decision Date | January 27, 2025 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |