SAB

Table Mounted Miniaturized Electromechanical Surgical System

Product code
SAB
Device name
Table Mounted Miniaturized Electromechanical Surgical System
Device class
Class 2
21 CFR
21 CFR 878.4962
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-08-20.

NumberDecision dateApplicantDevice nameSummary
K2608172026-08-20Virtual IncisionMIRA Surgical SystemPDF
DEN2300252024-02-23Virtual IncisionMIRA Surgical System

1 summaries are archived here for direct download.

Official FDA classification page: SAB
Classification and pathway per current FDA publications. Data from openFDA (CC0).