FDA product code SAQ: Electromechanical System For Open Microsurgery
SAQ is the FDA product code for electromechanical system for open microsurgery. It is a Class II device, regulated under 21 CFR 878.4963 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under SAQ, 4 in the last five years. The average 510(k) review took 107 days (median 110); 107 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electromechanical System For Open Microsurgery |
| Device class | Class II |
| Regulation | 21 CFR 878.4963 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SAQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 4 | 107 |
Compare with all 510(k) review times · Search every SAQ clearance
Top SAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Microinstruments, Inc. | 4 | 2025-11-10 |
Most recent SAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252287 | Medical Microinstruments, Inc. | Symani Surgical System | 2025-11-10 | 110 |
| K251510 | Medical Microinstruments, Inc. | Symani Surgical System | 2025-09-04 | 111 |
| K242368 | Medical Microinstruments, Inc. | Symani Surgical System | 2025-02-07 | 182 |
| K250014 | Medical Microinstruments, Inc. | Symani Surgical System (820-03830) | 2025-01-27 | 25 |
Recalls for SAQ devices
openFDA lists no recalls for product code SAQ.
Frequently asked questions
What is FDA product code SAQ?
SAQ is the FDA product code for electromechanical system for open microsurgery. It is a Class II device, regulated under 21 CFR 878.4963 and reviewed by the General and Plastic Surgery panel.
What device class is SAQ?
Class II, regulation 21 CFR 878.4963. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAQ?
Across 4 cleared submissions the average was 107 days from receipt to decision (median 110).
Which companies have the most SAQ clearances?
Medical Microinstruments, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code SAQ
- Run a recall and safety report across every SAQ manufacturer
- Watch product code SAQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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