510(k) K181756

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle by Apriomed AB — Product Code FCG

K181756 is an FDA 510(k) premarket notification submitted by Apriomed AB for the device "Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle". The FDA issued a decision of Substantially Equivalent on December 18, 2018. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Apriomed AB has at least 2 other 510(k) clearances on record.