FDA product code SIR: Integrated Operating Table-Electromechanical Surgical System
SIR is the FDA product code for integrated operating table-electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4966 and reviewed by the General and Plastic Surgery panel. Devices under SIR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Operating Table-Electromechanical Surgical System |
| Device class | Class II |
| Regulation | 21 CFR 878.4966 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for SIR devices
openFDA lists no recalls for product code SIR.
Frequently asked questions
What is FDA product code SIR?
SIR is the FDA product code for integrated operating table-electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4966 and reviewed by the General and Plastic Surgery panel.
What device class is SIR?
Class II, regulation 21 CFR 878.4966. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIR
- Run a recall and safety report across every SIR manufacturer
- Watch product code SIR 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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