510(k) · Cleared
ClearedEchosampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynetics Medical Products NV · HFF Aspirator, Endometrial
Cleared on Sep 8, 2004 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 8, 2004
- Review
- 120 days
- Class
- Class II
- Product code
- HFF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HFF devicesHFF Aspirator, Endometrial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFF
FDA has decided no HFF device since 2007.
Median 510(k) review, days · HFF
Too few HFF 510(k)s in any year since 2007 to give a median.
Recalls per year · HFF
No recall names HFF since 2007.
Adverse event reports per year · HFF
4in 2023
MAUDE reports naming product code HFF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (182 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041237: Echosampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041237
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026