510(k) K201001

Modulith SLX-F2 by Karl Storz Endoscopy America — Product Code LNS

K201001 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America for the device "Modulith SLX-F2". The FDA issued a decision of Substantially Equivalent on March 30, 2021. 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 has at least 10 other 510(k) clearances on record.