SIR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Integrated Operating Table-Electromechanical Surgical System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4966
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| OTTAVA™ Robotic Surgical System (DEN250068) | Auris Health, Inc., part of Johnson & Johnson MedTech | 2026-07-21 |
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Every clearance here is in the API, with alerts when new ones post.