510(k) K013721

SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER by CIVCO Medical Instruments Co., Inc. — Product Code ITX

K013721 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER". The FDA issued a decision of Substantially Equivalent on December 28, 2001. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.