# K112763: Matrixbrush Endometrial Sampler

- Pathway: 510(k) (Traditional)
- Applicant: Post Oak Innovations, Inc.
- Decided: Jun 18, 2012 after 270 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: 2 generations back to K881456 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082066: Tao Brush I.U.M.C. Endometrial Sampler, Cook Urological, Inc. (2008) Summary page 2.

## Indications for use
The MatrixBrush Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.

Source page: https://510kreport.com/device/K112763
Methodology: https://510kreport.com/methodology