Is Senhance Surgical System FDA approved or cleared?
Yes. Senhance Surgical System by Asensus Surgical, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2024.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Senhance Surgical System |
|---|---|
| Maker | Asensus Surgical, Inc. |
| Care area | Other |
| What it does | Robotic surgical system with haptic feedback and eye-tracking technology |
| FDA | 510(k), latest decision 2024 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | asensus.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
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