# K192534: CrossBay Endometrial Tissue Sampler (ETS)

- Pathway: 510(k) (Traditional)
- Applicant: Crossbay Medical
- Decided: Mar 25, 2020 after 191 days
- Product code: HHK (Curette, Suction, Endometrial (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1175
- 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 K915491 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021876: Mas with or Without Syringe, Marina Medical Instruments, Inc. (2003) Summary page 4.

## Most influential descendants
- K201952: CrossGlide ETS Plus (2020), 0 descendants of its own

## Indications for use
The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

Source page: https://510kreport.com/device/K192534
Methodology: https://510kreport.com/methodology