← Back to catalogue

Symani Surgical System

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN230032

by Mmi North America, Inc.

Identifiers

510(k) Number
DEN230032 FDA 510(k)
FDA Product Code
SAQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4963 FDA 510(k)
Regulation Number
878.4963 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
DENG FDA 510(k)

The Symani Surgical System is an electromechanical system for open microsurgery, designed to provide surgeons with precision and accuracy during microsurgical procedures. It is a software-controlled system with bedside human/device interfaces that allows qualified users to perform surgical techniques using instruments attached to an electromechanical arm.

The system is supplied for use in open microsurgical procedures and is intended to restore function and quality of life. It is authorized under FDA 510K clearance and is classified as a Class II device. The system is designed for use in general and plastic surgery applications, including head and neck procedures.

Frequently asked questions

What is the Symani Surgical System used for?

The Symani Surgical System is an electromechanical system designed for open microsurgery, providing surgeons with precision and accuracy during procedures. It is intended for use in general and plastic surgery applications, including head and neck procedures, to restore function and quality of life.

How is the Symani Surgical System supplied?

The system is supplied as a complete electromechanical system with software control and bedside human/device interfaces. It includes instruments that attach to an electromechanical arm, allowing qualified users to perform microsurgical techniques with enhanced precision.

What is the regulatory classification of the Symani Surgical System?

The Symani Surgical System is classified as a Class II device and has received FDA 510K clearance. It is authorized for use in open microsurgical procedures and is intended for general and plastic surgery applications, including head and neck procedures.

Can the Symani Surgical System be reused or is it single-use?

The device data does not specify whether the Symani Surgical System is designed for single-use or multiple uses. The system includes an electromechanical arm and instruments, but specific reuse instructions would be provided in the product's labeling and instructions for use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Symani - MMI, MMI - Discover the future of Robotic Microsurgery, PDF DEN230032, Symani Surgical System, MMI North America, Inc., Symani Surgical System - Head and Neck Robotic Surgery

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mmi North America, Inc.

Sources (1)

  • FDA 510(k) DEN230032 24 fields · synced Sep 26, 2026