K240595
- 510(k) number
- K240595
- Device name
- Utepreva Endometrial Sampler (UP01)
- Applicant
- Utepreva, LLC NY · US
- Product code
- HFE — Brush, Endometrial
- Decision date
- 2024-08-14
- Date received
- 2024-03-04
- 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: K240595.pdf
Official FDA record: K240595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.