510(k) K992114

KSEA CALCUSPLIT by Karl Storz Endoscopy — Product Code FFK

K992114 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "KSEA CALCUSPLIT". The FDA issued a decision of Substantially Equivalent on August 18, 1999. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.