K-number	DEN220047
Device name	Galen ES Cooperative Surgical Assistant Platform, Galen ES
Applicant	Galen Robotics
Product code	QXG
Device class	Class II
Decision date	Jul 19, 2023
Decision	Not Substantially Equivalent
Regulation	874.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Galen ES Cooperative Surgical Assistant Platform, Galen ES

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