510(k) K080365

MORCE POWER PLUS AND VARIOCARVE MORCELLATOR by NOUVAG AG — Product Code HET

K080365 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "MORCE POWER PLUS AND VARIOCARVE MORCELLATOR". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. NOUVAG AG has at least 10 other 510(k) clearances on record.