SAQ — Electromechanical System For Open Microsurgery Class II
FDA product code SAQ covers "Electromechanical System For Open Microsurgery", a Class II medical device regulated under 21 CFR 878.4963. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAQ
- Device Class
- Class II
- Regulation Number
- 878.4963
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252287 | Medical Microinstruments | Symani Surgical System | Nov 10, 2025 |
| K251510 | Medical Microinstruments | Symani Surgical System | Sep 4, 2025 |
| K242368 | Medical Microinstruments | Symani Surgical System | Feb 7, 2025 |
| K250014 | Medical Microinstruments | Symani Surgical System (820-03830) | Jan 27, 2025 |
| DEN230032 | Mmi North America | Symani Surgical System | Apr 5, 2024 |