Femasys, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
FemVue® Controlled Saline-Air Device (FSA-300)510(k)Dec 15, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Dec 15, 2025
FemVue MINI Saline-Air Device510(k)Nov 22, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Nov 22, 2024
FemChec Controlled Saline-Air Device (FCD-250)510(k)Sep 6, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2024
FemaSeed Intratubal Insemination510(k)Sep 22, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 22, 2023