510(k) K131656

MORCELLEX SIGMA GENERATOR by ETHICON, Inc. — Product Code HET

K131656 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "MORCELLEX SIGMA GENERATOR". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. ETHICON, Inc. has at least 10 other 510(k) clearances on record.