510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CMR Surgical Inc.

Cambridge Cambridgeshire, GB

CMR SURGICAL INC. appears in FDA device records in Cambridge Cambridgeshire, GB. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for CMR Surgical Inc. between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for CMR Surgical Inc., by decision year
YearClearances
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252111Versius Surgical System (Versius Plus)SCVSubstantially Equivalent
DEN230078Versius Surgical SystemSCVUnknown

Registered establishments

FDA registered establishments for CMR Surgical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30435118163043511816CMR SURGICAL INC.Ct Corporation, Wilmington, DE 19801 US2026No device listings on this registration
30154885593015488559CMR SURGICAL LIMITED1 Evolution Business Park, Milton Road, Cambridge Cambridgeshire CB24 9NG GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2717-2026Brand 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, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain