510(k) K911043

HEMISPHERE MULTIPLANE ENDORECTAL PROBE by Pie Medical Equipment B.V. — Product Code ITX

K911043 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "HEMISPHERE MULTIPLANE ENDORECTAL PROBE". The FDA issued a decision of Substantially Equivalent on October 9, 1991. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.