inforMED
SABClass II

Table Mounted Miniaturized Electromechanical Surgical System

General, Plastic Surgery · 21 CFR 878.4962

A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms

MDR events0All time
Recalls1All time
Registered firms3Currently listed
510(k) clearances1All time

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510(k) clearances

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