510(k) K011911

SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX by Richard Wolf Medical Instruments Corp. — Product Code FFK

K011911 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX". The FDA issued a decision of Substantially Equivalent on September 17, 2001. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.