Femasys, Inc.
Femasys, Inc. appears in FDA public data with 0 recalls, 9 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 15, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | December 15, 2025 |
| K242002 | FemVue MINI Saline-Air Device | November 22, 2024 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | September 6, 2024 |
| K231730 | FemaSeed Intratubal Insemination | September 22, 2023 |
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | December 20, 2012 |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | October 12, 2011 |
| K110288 | FEMVUE SALINE-AIR DEVICE | April 28, 2011 |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | April 7, 2010 |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | June 23, 2009 |