SAB — Table Mounted Miniaturized Electromechanical Surgical System Class II

FDA Device Classification

Classification Details

Product Code
SAB
Device Class
Class II
Regulation Number
878.4962
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN230025virtual incisionMIRA Surgical SystemFebruary 23, 2024