Galen ES Cooperative Surgical Assistant Platform, Galen ES— 510(k) DEN220047

Name: FDA 510(k) clearance DEN220047
Creator: U.S. Food and Drug Administration
Published: 2023-07-19

Unknown

Galen Robotics

FDA 510(k) clearance DEN220047 for Galen ES Cooperative Surgical Assistant Platform, Galen ES, Unknown on 2023-07-19. Applicant: Galen Robotics. Device class: 2.

Clearance details

Applicant: Galen Robotics
Product code: Code QXG
Device class: Class 2
Regulation: 21 CFR 874.4460
Advisory panel: Ear, Nose, Throat
Date received: 2022-07-22
Decision date: 2023-07-19
Decision: Unknown
Clearance type: Direct
Location: Baltimore, MD, US

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