# K201952: CrossGlide ETS Plus

- Pathway: 510(k) (Special)
- Applicant: Crossbay Medical
- Decided: Aug 5, 2020 after 22 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: 3 generations back to K915491 (1992). 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)
- K192534: CrossBay Endometrial Tissue Sampler (ETS), Crossbay Medical (2020) Summary page 4.

## Indications for use
The CrossGlide™ ETS Plus is indicated for use for sonohysterography and 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/K201952
Methodology: https://510kreport.com/methodology