K253403 is an FDA 510(k) clearance for the FemVue® Controlled Saline-Air Device (FSA-300). This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).
Submitted by Femasys, Inc. (Cumming, US). The FDA issued a Cleared decision on December 15, 2025, 76 days after receiving the submission on September 30, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K253403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | December 15, 2025 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF - Cannula, Manipulator/injector, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |