510(k) K981615

KSEA UROPUMP by KARL STORZ Endoscopy-America, Inc. — Product Code LJH

K981615 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA UROPUMP". The FDA issued a decision of Substantially Equivalent on July 8, 1998. 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.