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.
Summary
The OTTAVA Robotic Surgical System is from Auris Health, which the record lists as part of Johnson & Johnson MedTech. It's filed under SIR, integrated operating table-electromechanical surgical systems, and the record doesn't list the system's components.
Class II, 21 CFR 878.4966. General and Plastic Surgery is both the classification panel and the review panel. The record lists the submission type as Direct.
Auris Health filed from Santa Clara, California. The decision date came 215 calendar days after the received date (December 18, 2025 to July 21, 2026).
Clearance details
- Applicant
- Auris Health, Inc., part of Johnson & Johnson MedTech
- Product code
- Product 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.