Company · US
Femasys, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2025 | K253403 | FemVue® Controlled Saline-Air Device (FSA-300) Femasys, Inc. | LKF |
| Nov 22, 2024 | K242002 | FemVue MINI Saline-Air Device Femasys, Inc. | LKF |
| Sep 6, 2024 | K241693 | FemChec Controlled Saline-Air Device (FCD-250) Femasys, Inc. | LKF |
| Sep 22, 2023 | K231730 | FemaSeed Intratubal Insemination Femasys, Inc. | MQF |
| Dec 20, 2012 | K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 Femasys, Inc. | PCF |
| Oct 12, 2011 | K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE Femasys, Inc. | LKF |
| Apr 28, 2011 | K110288 | FEMVUE SALINE-AIR DEVICE Femasys, Inc. | LKF |
| Apr 7, 2010 | K100662 | FEMVUE CORNUAL BALLOON CATHETER Femasys, Inc. | LKF |
| Jun 23, 2009 | K083690 | FEMVUE(TM) CATHETER SYSTEM Femasys, Inc. | LKF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||