SAQ · Electromechanical System For Open Microsurgery
General, Plastic Surgery · 21 CFR 878.4963 · Class 2
Overview
| Product Code | SAQ |
|---|---|
| Device Name | Electromechanical System For Open Microsurgery |
| Regulation | 21 CFR 878.4963 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. | Nov 10, 2025 | SESE |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. | Sep 4, 2025 | SESE |
| K242368 | Symani Surgical System | Medical Microinstruments, Inc. | Feb 7, 2025 | SESE |
| K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | Jan 27, 2025 | SESE |
| DEN230032 | Symani Surgical System | Mmi North America, Inc. | Apr 5, 2024 | DENG |
Top Applicants
- Medical Microinstruments, Inc. — 4 clearances
- Mmi North America, Inc. — 1 clearance
