510(k) · Cleared
ClearedCrossBay Endometrial Tissue Sampler (ETS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossbay Medical · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Mar 25, 2020 as substantially equivalent to K021876 (Marina Medical Instruments, Inc., 2003) after a 191-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Mar 25, 2020
- Review
- 191 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915491 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915491 CurelleBioteque Corp. · 1992
- 1 generation backK021876 Mas with or Without SyringeMarina Medical Instruments, Inc. · 2003
- This deviceK192534 CrossBay Endometrial Tissue Sampler (ETS)Crossbay Medical · 2020
- Descendant · cites it directly · 0 of its ownK201952 CrossGlide ETS PlusCrossbay Medical · 2020
Most influential descendants
Showing 1 of 1 · See all- K201952CrossGlide ETS PlusCrossbay Medical · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915491 | Curelle | Bioteque Corp. | 1992 | — |
| −1 | K021876 | Mas with or Without Syringe | Marina Medical Instruments, Inc. | 2003 | — |
| 0 (this device) | K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | 2020 | — |
| +1 | K201952 | CrossGlide ETS Plus | Crossbay Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K021876 | Mas with or Without SyringeSummary page 4…duct Code: HHK (Curette, Suction, Endometrial [and accessories]) III. PREDICATE DEVICE INFORMATION The predicate device is the Marina Ampler Sampler (MAS), K021876. The predicate device has not been subject to a design‐related recall. IV. DEVICE DESCRIPTION The CrossGlide™ ETS, Endometrial… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201952 | CrossGlide ETS Plus | 2020 | 0 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201952 (Crossbay Medical, 2020) has gone furthest, with 0 descendants of its own.
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. 2020, 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 CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192534: CrossBay Endometrial Tissue Sampler (ETS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192534
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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