# K040189: Endometrial Sampling Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Oct 4, 2004 after 250 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 K854415 (1986). 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)
- K854415: Endometrial Pipelle, Unimar, Inc. (1986) Summary page 1.

## Indications for use
The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following: For histological biopsy of the endometrium & endo-cervix in post menopausal screening. Hormone therapy monitoring. Endometrial dating Detection of endometrial carcinoma Bacterial culturing

Source page: https://510kreport.com/device/K040189
Methodology: https://510kreport.com/methodology