K-number	DEN240023
Device name	SmartFlow Neuro Cannula
Applicant	ClearPoint Neuro, Inc.
Product code	SDG
Device class	Class II
Decision date	Nov 13, 2024
Decision	Not Substantially Equivalent
Regulation	882.4110

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Source

View the full FDA submission: accessdata.fda.gov

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SmartFlow Neuro Cannula

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