510(k) · Cleared
ClearedDisposable Endometrial Suction Curette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Suyun Medical Materials Co., Ltd. · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Apr 14, 2011 as substantially equivalent to K974819 (Select Medical Systems, Inc., 1998) after a 197-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 14, 2011
- Review
- 197 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974819 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974819 Selectcells (TM) MiniSelect Medical Systems, Inc. · 1998
- This deviceK102847 Disposable Endometrial Suction CuretteJiangsu Suyun Medical Materials Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974819 | Selectcells (TM) Mini | Select Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K102847 | Disposable Endometrial Suction Curette | Jiangsu Suyun Medical Materials Co., Ltd. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HHK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HHK device
- #1 K251882 Uterine Aspiration Setscore 10.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974819 | Selectcells (TM) MiniSummary page 2…mal or dysfunctional uterine bleeding - postmenopausal bleeding * endometrial dating 5. Predicate Device Identification: 510(k) Number: K974819 Trade/Proprietary Name: SelectCellsnhMini Submitter: Select Medical Systems, Inc Classification Name: Curette, Suctio… | 1998 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HHK devicesHHK Curette, Suction, Endometrial (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HHK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHK
Too few HHK 510(k)s in any year since 2007 to give a median.
Recalls per year · HHK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHK
9in 2025
MAUDE reports naming product code HHK, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102847: Disposable Endometrial Suction Curette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026