510(k) K011496

CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 by Richard Wolf Medical Instruments Corp. — Product Code FBO

K011496 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660". The FDA issued a decision of Substantially Equivalent on August 10, 2001. 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.