510(k) K092619

ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER by Civco — Product Code IYO

K092619 is an FDA 510(k) premarket notification submitted by Civco for the device "ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER". The FDA issued a decision of Substantially Equivalent on Nov 13, 2009. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Civco has 1 other 510(k) clearance on record.