Chrysalis Intelligence · Sponsors · Cmr Surgical Limited

Cmr Surgical Limited

Cambridge, GB · 2 510(k) clearances · 1 recalls

Total clearances
2
2024-10-11 → 2025-12-16
Last 12 months
1
Product codes
1
Most recent
2025-12-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SCV Modular Electromechanical Surgical System Class II General, Plastic Surgery 2 2025-12-16
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2026-06-09
DateSeverityStatusRecall # ProductCodeReason
2026-06-09 Class II Ongoing Z-2717-2026 Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Softwa… Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-12-16 K252111 Versius Surgical System (Versius Plus) SCV Class II General, Plastic Surgery
2024-10-11 DEN230078 Versius Surgical System SCV Class II General, Plastic Surgery