510(k) · Cleared
Recalled · 2002Wilson-Cook Triple Lumen Balloon Stone Extractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on Sep 19, 1995 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled once.
- Decided
- Sep 19, 1995
- Review
- 28 days
- Class
- Class II
- Product code
- GCA
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995
- Descendant · cites it directly · 10 of its ownK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK170292 Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK200173 Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK063677 Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK210660 Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040129Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004 · cites it directly10descendants
- K170292Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017 · 2 generations on6descendants
- K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020 · 3 generations on3descendants
- K063677Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007 · 2 generations on2descendants
- K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | — |
| +1 | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| +2 | K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017 | — |
| +3 | K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +2 | K063677 | Fusion Quattro Extraction Balloon XL | Wilson-Cook Medical, Inc. | 2007 | — |
| +4 | K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCA? 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 GCA device
- #1 K253013 Disposable Stone Retrieval Balloon Catheterscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040129 | Tri-EX Extraction Balloon with Multiple Sizing | 2004 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2002 | Not classified | Z-0068-04 | Other | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040129 (Wilson-Cook Medical, Inc., 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GCA devicesGCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GCA
Too few GCA 510(k)s in any year since 2007 to give a median.
Recalls per year · GCA
No recall names GCA since 2007.
Adverse event reports per year · GCA
24in 2025
MAUDE reports naming product code GCA, 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 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 36 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 2 | — | 0 | 38 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 2 | — | 0 | 20 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K953951 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953951: Wilson-Cook Triple Lumen Balloon Stone Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953951
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026