510(k) K180651

Uroview FD II by Pausch Medical GmbH — Product Code JAA

K180651 is an FDA 510(k) premarket notification submitted by Pausch Medical GmbH for the device "Uroview FD II". The FDA issued a decision of Substantially Equivalent on April 12, 2018. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Pausch Medical GmbH has at least 2 other 510(k) clearances on record.