SIR

Integrated Operating Table-Electromechanical Surgical System

Product code
SIR
Device name
Integrated Operating Table-Electromechanical Surgical System
Device class
Class 2
21 CFR
21 CFR 878.4966
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-21.

NumberDecision dateApplicantDevice nameSummary
DEN2500682026-07-21Auris Health, Inc., part of Johnson & …OTTAVA™ Robotic Surgical System
Official FDA classification page: SIR
Classification and pathway per current FDA publications. Data from openFDA (CC0).