K-number	K241209
Device name	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
Applicant	Cook Ireland, Ltd.
Product code	FCG
Device class	Class II
Decision date	Jul 29, 2024
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)

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EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)