510(k) K895614

CIVCO LATEX ULTRASOUND SHEATHS by CIVCO Medical Instruments Co., Inc. — Product Code IYO

K895614 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "CIVCO LATEX ULTRASOUND SHEATHS". The FDA issued a decision of Substantially Equivalent on December 14, 1989. 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.