Clearance Summary
FemVue® Controlled Saline-Air Device (FSA-300) received FDA 510(k) clearance under submission number K253403, sponsored by Femasys, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-12-15.
- Submission: K253403
- Applicant / Sponsor: Femasys, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2025-12-15
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.