Home / 510(k) Clearances / DEN220047

510(k) DEN220047

Galen ES Cooperative Surgical Assistant Platform, Galen ES by Galen Robotics — Product Code QXG

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: July 19, 2023
Date Received: July 22, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cooperative Powered Surgical Assist Device For Ent Surgery
Device Class: Class II
Regulation Number: 874.4460
Review Panel: EN
Submission Type

A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeons direct physical control of the instrument.