Versius Surgical System
FDA 510(k) clearance DEN230078 · decided 2024-10-11
Clearance details
- K-number
- DEN230078
- Device name
- Versius Surgical System
- Applicant
- Cmr Surgical Limited
- Decision
- Unknown
- Date received
- 2023-11-21
- Decision date
- 2024-10-11
- Days to decision
- 325 days
- Clearance type
- Direct
- 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
+ Add to Predicate Builder ◉ Watch Cmr Surgical Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
Recalls involving this device
No recalls on record reference this clearance.