510(k) K160198

UreTron MultiProbe Lithotripter System by Med-Sonics Corp. — Product Code FFK

K160198 is an FDA 510(k) premarket notification submitted by Med-Sonics Corp. for the device "UreTron MultiProbe Lithotripter System". The FDA issued a decision of Substantially Equivalent on February 23, 2016. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Med-Sonics Corp. has at least 2 other 510(k) clearances on record.