FDA 510(k) Applications Submitted by FEMASYS INC.

FDA 510(k) Number Submission Date Device Name Applicant
K242002 07/09/2024 FemVue MINI Saline-Air Device Femasys Inc.
K241693 06/12/2024 FemChec Controlled Saline-Air Device (FCD-250) Femasys Inc.
K231730 06/13/2023 FemaSeed Intratubal Insemination Femasys Inc.
K110288 02/01/2011 FEMVUE SALINE-AIR DEVICE FEMASYS INC.
K100662 03/08/2010 FEMVUE CORNUAL BALLOON CATHETER FEMASYS INC.
K110993 04/08/2011 FEMCHEC PRESSURE MANAGEMET DEVICE FEMASYS INC.
K122658 08/31/2012 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 FEMASYS INC.
K083690 12/12/2008 FEMVUE(TM) CATHETER SYSTEM FEMASYS INC.


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