K-number	K213831
Device name	Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Applicant	Gyrus Acmi, Inc.
Product code	GEI
Device class	Class II
Decision date	Jan 4, 2022
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

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