510(k) · Cleared
ClearedSonohysterography Biopsy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · PGK Cannula, Injector, Uterine, Endometrial Biopsy
Cleared on Jun 29, 2006 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 29, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- PGK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK060908 Sonohysterography Biopsy DeviceCook Urological, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK133144 Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133144Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060908 | Sonohysterography Biopsy Device | Cook Urological, Inc. | 2006 | — |
| +1 | K133144 | Sonosure Sonohysterography & Endometrial Sampling Device | Crossbay Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (9)
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 |
|---|---|---|---|
| * | — | Tampa Catheter Named without a submission number | |
| * | — | EZ-HSG Catheter Named without a submission number | |
| * | — | Cook Hysterocath Named without a submission number | |
| * | — | Goldstein Sonohysterography Catheter Named without a submission number | |
| * | — | Probet Named without a submission number | |
| * | — | Uterine Explora Model I Named without a submission number | |
| * | — | Wallace Suresample Endometrial Sampler Named without a submission number | |
| * | — | Pipelle de Cornier Endometrial Suction Curette Named without a submission number | |
| * | — | Aspiracath Named without a submission number |
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 |
|---|---|---|---|
| K133144 | Sonosure Sonohysterography & Endometrial Sampling Device | 2014 | 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?
- Of its descendants, K133144 (Crossbay Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
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.
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 Cook® Sonchysterography Biopsy Catheter is used to access fhe uterine cavily for sonchysterography and to ebtain endometrial biopsy, if indicated, utiiizing the same device. The deviceis a single catheter designed to perform saline infusion sonchysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060908: Sonohysterography Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060908
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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