510(k) DEN250068
DEN250068 is an FDA 510(k) premarket notification submitted by Auris Health, Inc., Part Of Johnson & Johnson MedTech for the device "OTTAVA Robotic Surgical System". The FDA issued a decision of De Novo Granted on Jul 21, 2026. The device falls under product code SIR (Integrated Operating Table-Electromechanical Surgical System), a Class II device regulated under 21 CFR 878.4966.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jul 21, 2026
- Date Received
- Dec 18, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Operating Table-Electromechanical Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4966
- Review Panel
- SU
- Submission Type
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.