Clearance Summary
Béa Applicator (BAP-GB-01) received FDA 510(k) clearance under submission number K242031, sponsored by Stepone Fertility Ltd (T/A Béa Fertility). 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 2025-04-02.
- Submission: K242031
- Applicant / Sponsor: Stepone Fertility Ltd (T/A Béa Fertility)
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 2025-04-02
Classification & Regulation
This clearance is catalogued under FDA product code HDR and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.