SIR — Integrated Operating Table-Electromechanical Surgical System Class II
FDA product code SIR covers "Integrated Operating Table-Electromechanical Surgical System", a Class II medical device regulated under 21 CFR 878.4966. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIR
- Device Class
- Class II
- Regulation Number
- 878.4966
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250068 | Auris Health, Inc., Part Of Johnson And Johnson Medtech | OTTAVA Robotic Surgical System | Jul 21, 2026 |