510(k) · Cleared
ClearedFusion Quattro Extraction Balloon XL
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 Jan 5, 2007 as substantially equivalent to K040129 (Wilson-Cook Medical, Inc., 2004) after a 25-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 5, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- GCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953951 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995 · Recalled
- 1 generation backK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- This deviceK063677 Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK200247 Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK101095 Direct Peroral Cholangioscopy BalloonWilson-Cook Medical, Inc. · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | 1 |
| −1 | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| 0 (this device) | K063677 | Fusion Quattro Extraction Balloon XL | Wilson-Cook Medical, Inc. | 2007 | — |
| +1 | K200247 | Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. | 2020 | — |
| +1 | K101095 | Direct Peroral Cholangioscopy Balloon | Wilson-Cook Medical, Inc. | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K040129 | Tri-EX Extraction Balloon with Multiple SizingSummary page 1…ary, Surgical (21 CFR 876.501 0, Product Code 18 GCA) Legally Marketed Devices: Tri-Ex Extraction Balloon with Multiple Sizing (K040129) Description of the Device: The subject extraction balloon represents modifications ma… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 1 company; a new generation was cleared every 8.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K200247 (Wilson-Cook Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040129.
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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Used for endoscopic removal of stones in the biliary system and for contrast injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063677: Fusion Quattro Extraction Balloon XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063677
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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