Clearance Summary
FemChec Controlled Saline-Air Device (FCD-250) received FDA 510(k) clearance under submission number K241693, 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 2024-09-06.
- Submission: K241693
- Applicant / Sponsor: Femasys, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2024-09-06
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.