510(k) K100662

FEMVUE CORNUAL BALLOON CATHETER by Femasys, Inc. — Product Code LKF

K100662 is an FDA 510(k) premarket notification submitted by Femasys, Inc. for the device "FEMVUE CORNUAL BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on April 7, 2010. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Femasys, Inc. has at least 8 other 510(k) clearances on record.