510(k) K935163

CONTINUOUS IRRIGATION CYSTOURETHROSCOPE by Richard Wolf Medical Instruments Corp. — Product Code FBO

K935163 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "CONTINUOUS IRRIGATION CYSTOURETHROSCOPE". The FDA issued a decision of Substantially Equivalent on September 7, 1994. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.