510(k) K162992

Karl Storz UROMAT E.A.S.I. by Karl Storz Endoscopy America, Inc. — Product Code LJH

K162992 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "Karl Storz UROMAT E.A.S.I.". The FDA issued a decision of Substantially Equivalent on July 7, 2017. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.