510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220047Unknown

Galen ES Cooperative Surgical Assistant Platform, Galen ES

Galen Robotics, Baltimore MD / Direct, Unknown
FDA source (opens on fda.gov)

DEN220047 is the FDA 510(k) clearance record for Galen ES Cooperative Surgical Assistant Platform, Galen ES, a class II device, cleared for Galen Robotics on under FDA product code QXG (Cooperative Powered Surgical Assist Device For Ent Surgery). FDA's definition for product code QXG reads: "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...". FDA records list one 510(k) clearance for Galen Robotics. As of , FDA records show no recalls naming DEN220047.

Clearance record

Decision date
Received
(362 days to decision)
Product code
QXG Cooperative Powered Surgical Assist Device For Ent Surgery
Regulation
21 CFR 874.4460
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Galen Robotics 1100 Wicomico St., Suite 725, Baltimore MD
Third party review
No

Clearances, product code QXG

Trailing 12 months

FDA records hold no clearances under product code QXG in the trailing twelve months.

FDA records show no clearances under product code QXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260