K242031
- 510(k) number
- K242031
- Device name
- Béa Applicator (BAP-GB-01)
- Applicant
- Stepone Fertility Ltd (T/A Béa Fertility) GB
- Product code
- HDR — Cap, Cervical
- Decision date
- 2025-04-02
- Date received
- 2024-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242031.pdf
Official FDA record: K242031
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.