510(k) DEN230084

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

October 25, 2024

Date Received

December 15, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

Device Class

Class II

Regulation Number

878.4965

Review Panel

SU

Submission Type

An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use.