K-number	K230909
Device name	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
Applicant	Cook Ireland, Ltd.
Product code	FCG
Device class	Class II
Decision date	May 30, 2023
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 Ultrasound Biopsy Needle (ECHO-BX-3-22)

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EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)