Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4966](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4966) → SIR — Integrated Operating Table-Electromechanical Surgical System

# SIR · Integrated Operating Table-Electromechanical Surgical System

_General, Plastic Surgery · 21 CFR 878.4966 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/SIR

## Overview

- **Product Code:** SIR
- **Device Name:** Integrated Operating Table-Electromechanical Surgical System
- **Regulation:** [21 CFR 878.4966](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4966)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250068](/device/DEN250068.md) | OTTAVA™ Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | Jul 21, 2026 | DENG |

## Top Applicants

- Auris Health, Inc., part of Johnson & Johnson MedTech — 1 clearance

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**Source:** [https://fda-staging.innolitics.com/productcode/SIR](https://fda-staging.innolitics.com/productcode/SIR)

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