510(k) K242002

FemVue MINI Saline-Air Device by Femasys, Inc. — Product Code LKF

K242002 is an FDA 510(k) premarket notification submitted by Femasys, Inc. for the device "FemVue MINI Saline-Air Device". The FDA issued a decision of Substantially Equivalent on November 22, 2024. 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.