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510(k) K250725

Device
Hugo? RAS System
Applicant
Covidien, LLC
510(k) number
K250725
Product code
SCV
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-03
Date received
2025-03-10
Regulation
878.4964
Classification name
Modular Electromechanical Surgical System
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shriya Kafle
Address
60 Middletown Ave. North Haven CT US 06473 06473

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SCV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252111Versius Surgical System (Versius Plus)Cmr Surgical Limited2025-12-16
DEN230078Versius Surgical SystemCmr Surgical Limited2024-10-11