Modular Electromechanical Surgical System
General, Plastic Surgery · 21 CFR 878.4964
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.
Recent MDR events
1,552 adverse event reports on file
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04738
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04739
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04740
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04742
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04748
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04751
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04757
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04759
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04760
- Hugo¿ RAS SystemJul 31, 2026MalfunctionSurgical1219930-2026-04764
Event type breakdown
Registered firms
15 firms currently registered for this product code
Covidien
North Haven, CT, US
Cmr Surgical Limited
Cambridge Cambridgeshire, GB
Schivo
Waterford Waterford (City and County), IE
Sterigenics Uk Limited
Alfreton Derbyshire, GB
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Bowa-electronic Gmbh & Co. Kg
GOMARINGEN Baden-Wurttemberg, DE
Plexus Corp.
BUFFALO GROVE, IL, US
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Covidien
- Santo Domingo, DO
Das Medical International, Srl
La Romana, DO
Pmc Smart Solutions, Llc
Shelbyville, IN, US
Micro Stamping Corporation
SOMERSET, NJ, US
Amphenol Alden Products Company
Hermosillo Sonora, MX
Clinical Polymer Technologies Ltd
Coalville Leicestershire, GB
510(k) clearances
4 clearances for this product code