510(k) K033113

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 by Richard Wolf Medical Instruments Corp. — Product Code HIH

K033113 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753". The FDA issued a decision of Substantially Equivalent on December 23, 2003. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.