510(k) K943863

NEEDLE GUIDE by Biopsys Medical, Inc. — Product Code IYN

K943863 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.