510(k) K875236

TRANS/P NEEDLE GUIDE by CIVCO Medical Instruments Co., Inc. — Product Code IYO

K875236 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "TRANS/P NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on April 15, 1988. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.