510(k) K111058

URETRON MODEL URT by Med-Sonics Corp. — Product Code FFK

K111058 is an FDA 510(k) premarket notification submitted by Med-Sonics Corp. for the device "URETRON MODEL URT". The FDA issued a decision of Substantially Equivalent on March 30, 2012. 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.