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HFE

Brush, Endometrial

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)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-14.

NumberDecision dateApplicantDevice nameSummary
K2405952024-08-14Utepreva, LLCUtepreva Endometrial Sampler (UP01)PDF

1 summaries are archived here for direct download.

Official FDA classification page: HFE
Classification and pathway per current FDA publications. Data from openFDA (CC0).