510(k) K253403

FemVue® Controlled Saline-Air Device (FSA-300) by Femasys, Inc. — Product Code LKF

K253403 is an FDA 510(k) premarket notification submitted by Femasys, Inc. for the device "FemVue® Controlled Saline-Air Device (FSA-300)". The FDA issued a decision of Substantially Equivalent on December 15, 2025. 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.