Medical Device Manufacturer · US , Suwanee , GA

Femasys, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2009

Recent clearances: FemVue® Controlled Saline-Air Device (FSA-300), FemVue MINI Saline-Air Device, FemChec Controlled Saline-Air Device (FCD-250)

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Femasys, Inc. Obstetrics & Gynecology ✕

9 devices

1-9 of 9

Cleared Dec 15, 2025

FemVue® Controlled Saline-Air Device (FSA-300)

Obstetrics & Gynecology · 76d

Cleared Nov 22, 2024

FemVue MINI Saline-Air Device

Obstetrics & Gynecology · 136d

Cleared Sep 06, 2024

FemChec Controlled Saline-Air Device (FCD-250)

Obstetrics & Gynecology · 86d

Cleared Sep 22, 2023

FemaSeed Intratubal Insemination

Obstetrics & Gynecology · 101d

Cleared Dec 20, 2012

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF...

Obstetrics & Gynecology · 111d

Cleared Oct 12, 2011

FEMCHEC PRESSURE MANAGEMET DEVICE

Obstetrics & Gynecology · 187d

Cleared Apr 28, 2011

FEMVUE SALINE-AIR DEVICE

Obstetrics & Gynecology · 86d

Cleared Apr 07, 2010

FEMVUE CORNUAL BALLOON CATHETER

Obstetrics & Gynecology · 30d

Cleared Jun 23, 2009

FEMVUE(TM) CATHETER SYSTEM

Obstetrics & Gynecology · 193d