Product code QXG

Device name

Cooperative Powered Surgical Assist Device For Ent Surgery

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.4460

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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 surgeon’s direct physical control of the instrument.

Source

FDA openFDA device classification dataset