510(k) K964276

ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR by Richard Wolf Medical Instruments Corp. — Product Code HEW

K964276 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR". The FDA issued a decision of Substantially Equivalent on November 25, 1997. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.