# K102847: Disposable Endometrial Suction Curette

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Suyun Medical Materials Co., Ltd.
- Decided: Apr 14, 2011 after 197 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: 1 generation back to K974819 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974819: Selectcells (TM) Mini, Select Medical Systems, Inc. (1998) Summary page 2.

## Indications for use
The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: * Endometrial cancer detection * Determine response to estrogen replacement therapy * Detection of pathology resulting in: - Infertility - menstrual disorders - abnormal or dysfunctional uterine bleeding - postmenopausal bleeding * Endometrial dating

Source page: https://510kreport.com/device/K102847
Methodology: https://510kreport.com/methodology