K-number	K181756
Device name	Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Applicant	Apriomed AB
Product code	FCG
Device class	Class II
Decision date	Dec 18, 2018
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

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