510(k) K992152

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF by CIVCO Medical Instruments Co., Inc. — Product Code ITX

K992152 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF". The FDA issued a decision of Substantially Equivalent on August 17, 1999. 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.