510(k) DEN250068 · SIR Integrated Operating Table-Electromechanical Surgical System
OTTAVA Robotic Surgical System
| Applicant | Auris Health, Inc., part of Johnson & Johnson MedTech, Santa Clara CA, US |
| Decision | Unknown, Jul 21, 2026 |
| Received | Dec 18, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250068
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.