510(k) K252111 ยท SCV Modular Electromechanical Surgical System
Versius Surgical System (Versius Plus)
| Applicant | Cmr Surgical Limited, Cambridge, GB |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Jul 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | CMR SURGICAL LIMITED Brand Name: Versius Surgical System US
Product Name: Vesius Surgeon Console US
Model/Catalog Number: V-SS-1020
Software Version: Pratchett 1 version 62.1
Product Description: The Versius Surgical Syst Open, Classified |
SCV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.