Versius Surgical System (Versius Plus)
FDA 510(k) clearance K252111 · decided 2025-12-16
Clearance details
- K-number
- K252111
- Device name
- Versius Surgical System (Versius Plus)
- Applicant
- Cmr Surgical Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-07-07
- Decision date
- 2025-12-16
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- SCV
- Device class
- 2
- Regulation number
- 878.4964
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cambridge, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Anovo Surgical System (6Ne) (K260804) | Momentis Surgical , Ltd. | 2026-07-22 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
| Versius Surgical System (DEN230078) | Cmr Surgical Limited | 2024-10-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catal recall (Z-2717-2026) | CMR SURGICAL LIMITED | 2026-07-09 |