510(k) clearances

Versius Surgical System (Versius Plus)

Cmr Surgical Limited · General, Plastic Surgery

K261252Substantially EquivalentTraditionalSCV
Open FDA's page for this record
Third party flag
N
City
Cambridge
Advisory committee description
General, Plastic Surgery
Address 1
1 Evolution Business Park, Milton Rd.
Statement or summary
Summary
Product code
SCV
Zip code
CB24 9NG
Applicant
Cmr Surgical Limited
Decision date
2026-10-21
Decision code
SESE
Country code
GB
Device name
Versius Surgical System (Versius Plus)
Advisory committee
SU
Contact
Nickie Power
K number
K261252
Date received
2026-04-16
Review advisory committee
SU
Postal code
CB24 9NG
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Modular Electromechanical Surgical System
Medical specialty description
General, Plastic Surgery
Regulation number
878.4964
Device class
2
Registration number
3017636737, 3008889904, 1219930, 3018094310, 9611102, 1717344, 3007029079, 2248148, 3004105270, 3015488559, 3010372554, 3014155960, 9614969, 3010193531, 3008132398, 3010408671, 9612501, 3026612481
FEI number
3002807091, 3026612481, 3017636737, 1219930, 1000222372, 3018094310, 3002808001, 1717344, 3007029079, 1000499348, 3004105270, 3015488559, 3010372554, 3014155960, 3010193531, 3008889904, 3010408671, 3003495548
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.