510(k) K992027

KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR by Karl Storz Endoscopy — Product Code HIH

K992027 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR". The FDA issued a decision of Substantially Equivalent on September 9, 1999. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.