HFE
- Product code
- HFE
- Device name
- Brush, Endometrial
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1100
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240595 | 2024-08-14 | Utepreva, LLC | Utepreva Endometrial Sampler (UP01) |
Official FDA classification page: HFE
Classification and pathway per current FDA publications. Data from openFDA (CC0).