510(k) K973251

KSEA CALCUSON by KARL STORZ Endoscopy-America, Inc. — Product Code FEO

K973251 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA CALCUSON". The FDA issued a decision of Substantially Equivalent on June 22, 1998. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.