Femasys, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253403FemVue® Controlled Saline-Air Device (FSA-300)December 15, 2025
K242002FemVue MINI Saline-Air DeviceNovember 22, 2024
K241693FemChec Controlled Saline-Air Device (FCD-250)September 6, 2024
K231730FemaSeed Intratubal InseminationSeptember 22, 2023
K122658FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009December 20, 2012
K110993FEMCHEC PRESSURE MANAGEMET DEVICEOctober 12, 2011
K110288FEMVUE SALINE-AIR DEVICEApril 28, 2011
K100662FEMVUE CORNUAL BALLOON CATHETERApril 7, 2010
K083690FEMVUE(TM) CATHETER SYSTEMJune 23, 2009