OTTAVA™ Robotic Surgical System
FDA 510(k) clearance DEN250068 · decided 2026-07-21
Clearance details
- K-number
- DEN250068
- Device name
- OTTAVA™ Robotic Surgical System
- Applicant
- Auris Health, Inc., part of Johnson & Johnson MedTech
- Decision
- Unknown
- Date received
- 2025-12-18
- Decision date
- 2026-07-21
- Days to decision
- 215 days
- Clearance type
- Direct
- Product code
- SIR
- Device class
- 2
- Regulation number
- 878.4966
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.