510(k) K991563

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C by Henke Sass Wolf Of America, Inc. — Product Code HIH

K991563 is an FDA 510(k) premarket notification submitted by Henke Sass Wolf Of America, Inc. for the device "CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C". The FDA issued a decision of Substantially Equivalent on Oct 13, 1999. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Henke Sass Wolf Of America, Inc. has 8 other 510(k) clearances on record.