510(k) K120769

MODULTH SLK by KARL STORZ Endoscopy-America, Inc. — Product Code LNS

K120769 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "MODULTH SLK". The FDA issued a decision of Substantially Equivalent on June 12, 2012. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.