510(k) K011700

MODULITH SLK LITHOTRIPTER by Karl Storz Endoscopy — Product Code LNS

K011700 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "MODULITH SLK LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on August 16, 2002. 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 has at least 10 other 510(k) clearances on record.