Medical Microinstruments, Inc. · Class II · Cleared Sep 4, 2025
| K-number | K251510 |
| Device name | Symani Surgical System |
| Applicant | Medical Microinstruments, Inc. |
| Product code | SAQ |
| Device class | Class II |
| Decision date | Sep 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4963 |
The Symani Surgical System is an electromechanical device designed for microsurgical procedures on small blood vessels and lymphatic ducts (0.1-2.5 mm diameter) in open free-flap and lymphatic surgery. It provides motion scaling (7x to 20x) to reduce surgeon tremor and improve precision, and includes wristed instruments for enhanced tissue manipulation and suturing in breast, mouth, scalp, and extremity procedures.
The subject device adds a Digital Workstation accessory for displaying surgical images from 3D microscopes with overlay information from the Symani GUI using Ultra High Definition (UHD) technology. The core subsystems (Cart with Macropositioner and Micromanipulators, Console, and Instruments) remain unchanged from the predicate device.
Not stated in this summary.
The subject device has identical intended use and indications for use as the predicate device (K242358). The only addition is a Digital Workstation accessory that functions as a display interface without introducing new technological characteristics to the core surgical system components. Performance testing for EMI/EMC, electrical safety, software, cybersecurity, and human factors confirmed the Digital Workstation is as safe and effective as the predicate device.
View the full FDA submission: accessdata.fda.gov