OTTAVA Robotic Surgical System— 510(k) DEN250068
UnknownAuris Health, Inc., part of Johnson & Johnson MedTech
FDA 510(k) clearance DEN250068 for OTTAVA Robotic Surgical System, Unknown on 2026-07-21. Applicant: Auris Health, Inc., part of Johnson & Johnson MedTech. Device class: 2.
Clearance details
- Applicant
- Auris Health, Inc., part of Johnson & Johnson MedTech
- Product code
- Code SIR
- Device class
- Class 2
- Regulation
- 21 CFR 878.4966
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Santa Clara, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.