FDA product code SAB: Table Mounted Miniaturized Electromechanical Surgical System
SAB is the FDA product code for table mounted miniaturized electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4962 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under SAB, 1 in the last five years. The average 510(k) review took 160 days (median 160); 160 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for SAB devices, 1 initiated in the last five years.
Definition
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms
Classification
| Field | Value |
|---|---|
| Device name | Table Mounted Miniaturized Electromechanical Surgical System |
| Device class | Class II |
| Regulation | 21 CFR 878.4962 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SAB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 160 |
Compare with all 510(k) review times · Search every SAB clearance
Top SAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Virtual Incision | 1 | 2026-08-20 |
Most recent SAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260817 | Virtual Incision | MIRA Surgical System | 2026-08-20 | 160 |
Recalls for SAB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2025-04-23.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code SAB?
SAB is the FDA product code for table mounted miniaturized electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4962 and reviewed by the General and Plastic Surgery panel.
What device class is SAB?
Class II, regulation 21 CFR 878.4962. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAB?
Across 1 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most SAB clearances?
Virtual Incision (1).
Have SAB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code SAB
- Run a recall and safety report across every SAB manufacturer
- Watch product code SAB 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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