SIR
- Product code
- SIR
- Device name
- Integrated Operating Table-Electromechanical Surgical System
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4966
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250068 | 2026-07-21 | Auris Health, Inc., part of Johnson & … | OTTAVA Robotic Surgical System | — |
Official FDA classification page: SIR
Classification and pathway per current FDA publications. Data from openFDA (CC0).