DeviceClearance

Product code QXG— Ear, Nose, Throat

Galen ES Cooperative Surgical Assistant Platform, Galen ES

Classification name
Cooperative Powered Surgical Assist Device For Ent Surgery
Device class
Class 2
Regulation
21 CFR 874.4460
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QXG under 21 CFR 874.4460, via openFDA

Market context for product code QXG

FDA has cleared 1 device under product code QXG, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXG

Recent clearances under product code QXG

Data sourced from openFDA. This site is unofficial and independent of the FDA.