510(k) · Cleared
ClearedSonosure Sonohysterography & Endometrial Sampling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossbay Medical, Inc. · PGK Cannula, Injector, Uterine, Endometrial Biopsy
Cleared on Mar 19, 2014 as substantially equivalent to K060908 (Cook Urological, Inc., 2006) and 1 other predicate after a 153-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Mar 19, 2014
- Review
- 153 days
- Class
- Class II
- Product code
- PGK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K881456 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK881456 Pipelle DE Cornier Endometrial Suction CuretteLaboratoire Ccd C/O Washington Regulatory Services · 1988
- 1 generation backK082066 Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · Recalled
- This deviceK133144 Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881456 | Pipelle DE Cornier Endometrial Suction Curette | Laboratoire Ccd C/O Washington Regulatory Services | 1988 | — |
| −1 | K082066 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Urological, Inc. | 2008 | 1 |
| 0 (this device) | K133144 | Sonosure Sonohysterography & Endometrial Sampling Device | Crossbay Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 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 PGK? 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? (2)
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 |
|---|---|---|---|
| * | K060908 | Sonohysterography Biopsy DeviceSummary page 1…ector, uterine, enodlometrial biopsy) HIFE (endometrial brush) Equivalent Devices: Cook's Sonohysterography Biopsy Device (K060908 - 29 Jun 2006) Cook's Tao Endlometrial Sampling Brush (1(082066 - 07 Nov 2008) Device Descripti… | 2006 |
| * | K082066 | Tao Brush I.U.M.C. Endometrial SamplerSummary page 1…quivalent Devices: Cook's Sonohysterography Biopsy Device (K060908 - 29 Jun 2006) Cook's Tao Endlometrial Sampling Brush (1(082066 - 07 Nov 2008) Device Description: The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterogr… | 2008 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All PGK devicesPGK Cannula, Injector, Uterine, Endometrial Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGK
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PGK
Too few PGK 510(k)s in any year since 2007 to give a median.
Recalls per year · PGK
No recall names PGK since 2007.
Adverse event reports per year · PGK
No MAUDE report names PGK since 2007.
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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Crosseay SonsoSure Sonohysterography and Endometrial Sampling Device is Indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if Indicated, utilizing the same device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133144: Sonosure Sonohysterography & Endometrial Sampling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133144
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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