510(k) K111014

LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES by Lsi Solutions, Inc. — Product Code HEW

K111014 is an FDA 510(k) premarket notification submitted by Lsi Solutions, Inc. for the device "LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Lsi Solutions, Inc. has at least 10 other 510(k) clearances on record.