# K041237: Echosampler

- Pathway: 510(k) (Traditional)
- Applicant: Gynetics Medical Products NV
- Decided: Sep 8, 2004 after 120 days
- Product code: HFF (Aspirator, Endometrial)
- Device class: 2
- Regulation: 21 CFR 884.1060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EchoSampler™ is a single-use, sterile, disposable curette for: * Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity * Obtaining histological biopsy of the glandular epithelium and superficial chorionic layers of the uterine endometrial wall or sample extraction of uterine menstrual content for any of the following: a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable, b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia d) Identification of specific uterine pathogens by bacterial culturing of uterine samples e) Inadequate imaging of the endometrium by endovaginal sonography f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris, g) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts h) Congenital abnormalities and/or anatomic variants of the uterine cavity i) Infertility and habitual abortion

Source page: https://510kreport.com/device/K041237
Methodology: https://510kreport.com/methodology