SAQ
5 FDA 510(k) clearances · Product code
111 daysmedian time to decision
346 days90th percentile
5clearances measured
FDA profile
- Official device name
- Electromechanical System For Open Microsurgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4963
- Medical specialty
- General, Plastic Surgery
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Symani Surgical System (K252287) | Medical Microinstruments, Inc. | 2025-11-10 |
| Symani Surgical System (K251510) | Medical Microinstruments, Inc. | 2025-09-04 |
| Symani Surgical System (K242368) | Medical Microinstruments, Inc. | 2025-02-07 |
| Symani Surgical System (820-03830) (K250014) | Medical Microinstruments, Inc. | 2025-01-27 |
| Symani Surgical System (DEN230032) | Mmi North America, Inc. | 2024-04-05 |
Track SAQ automatically
Every clearance here is in the API, with alerts when new ones post.