# K240595: Utepreva Endometrial Sampler (UP01)

- Pathway: 510(k) (Traditional)
- Applicant: Utepreva, LLC
- Decided: Aug 14, 2024 after 163 days
- Product code: HFE (Brush, Endometrial)
- Device class: 2
- Regulation: 21 CFR 884.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K881456 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170603: Tao Brush I.U.M.C. Endometrial Sampler, Cook Incorporated (2017) Summary page 4.

## Indications for use
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.

Source page: https://510kreport.com/device/K240595
Methodology: https://510kreport.com/methodology