Data / Medical devices / United Kingdom / CMR Surgical Limited
CMR Surgical Limited: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 1 510(k) clearance
CMR Surgical Limited is registered with the FDA (registration 3015488559) in Cambridge Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015488559
- Address
- 1 Evolution Business Park, Milton Road, Cambridge Cambridgeshire, United Kingdom, CB24 9NG
- Owner or operator
- CMR Surgical Limited (10094768)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2025
- Registered through
- 2026
- Brand names listed
- Versius Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Modular Electromechanical Surgical System | SCV | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K252111 | Versius Surgical System (Versius Plus) | SCV | Substantially Equivalent | Cmr Surgical Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 9, 2026 | 99280 | Class II | Ongoing | 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 System is a modular, ope | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. | accessdata.fda.gov |
Compare with other makers
Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.