FDA 510(k) Application Details - DEN220047

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220047
Device Name	Galen ES Cooperative Surgical Assistant Platform, Galen ES
Applicant	Galen Robotics 1100 Wicomico St., Ste. 725 Baltimore, MD 21230 US Other 510(k) Applications for this Company
Contact	Robert Lawery Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2022
Decision Date	07/19/2023
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review