K-number	K244029
Device name	ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
Applicant	Endorobotics Co., Ltd.
Product code	FDF
Device class	Class II
Decision date	Sep 24, 2025
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

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