QXG · Class II · 21 CFR 874.4460

FDA Product Code QXG: Cooperative Powered Surgical Assist Device For Ent Surgery

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.

Leading manufacturers include Galen Robotics.

1
Total
0
Cleared
362d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cooperative Powered Surgical Assist Device For Ent Surgery Devices (Product Code QXG)

1 devices
1–1 of 1
Not Cleared Jul 19, 2023
Galen ES Cooperative Surgical Assistant Platform, Galen ES
DEN220047
Galen Robotics
Ear, Nose, Throat · 362d

About Product Code QXG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXG since 2023, with 0 receiving FDA clearance (average review time: 362 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXG devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →