# K941298: Iumc Endometrial Sampler

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Feb 13, 1995 after 333 days
- Product code: HFE (Brush, Endometrial)
- Device class: 2
- Regulation: 21 CFR 884.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082066: Tao Brush I.U.M.C. Endometrial Sampler (2008), 4 descendants of its own
- K170603: Tao Brush I.U.M.C. Endometrial Sampler (2017), 1 descendant of its own
- K240595: Utepreva Endometrial Sampler (UP01) (2024), 0 descendants of its own
- K133144: Sonosure Sonohysterography & Endometrial Sampling Device (2014), 0 descendants of its own
- K112763: Matrixbrush Endometrial Sampler (2012), 0 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-1416-2009: There is an ink on the brush which has not been tested for use with the Tao Brush.

Source page: https://510kreport.com/device/K941298
Methodology: https://510kreport.com/methodology