DEN250068
- 510(k) number
- DEN250068
- Device name
- OTTAVA Robotic Surgical System
- Applicant
- Auris Health, Inc., part of Johnson & Johnson MedTech CA · US
- Product code
- SIR — Integrated Operating Table-Electromechanical Surgica
- Decision date
- 2026-07-21
- Date received
- 2025-12-18
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN250068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.