HDR
- Product code
- HDR
- Device name
- Cap, Cervical
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 29
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242031 | 2025-04-02 | Stepone Fertility Ltd (T/A Béa Fertili | Béa Applicator (BAP-GB-01) |
Official FDA classification page: HDR
Classification and pathway per current FDA publications. Data from openFDA (CC0).