# Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited

**Predicate Speed & CAPA Advisory Opportunity Score:** 54/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261252 |
| Device | Versius Surgical System (Versius Plus) |
| Applicant | Cmr Surgical Limited |
| Specialty / panel | General, Plastic Surgery |
| Product code | SCV |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-10-21 |
| Review time (days) | 188 |
| Third-party review | No |
| Applicant location | Cambridge, GB |

## Why this score
- 188-day review, longer than typical.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261252). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.