510(k) · Cleared
ClearedCotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 13, 2017 as substantially equivalent to K851960 (Wilson-Cook Medical, Inc., 1985) and 1 other predicate after a 140-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Oct 13, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851956 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK851956 VPDS-1 Vennes Pancreatic Dilation SetWilson-Cook Medical, Inc. · 1985
- This deviceK171548 Cotton Graduated Dilation Catheter, Fusion Biliary Dilation…Wilson-Cook Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK241801 Tornus ESAsahi Intecc Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241801Tornus ESAsahi Intecc Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851956 | VPDS-1 Vennes Pancreatic Dilation Set | Wilson-Cook Medical, Inc. | 1985 | — |
| 0 (this device) | K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter… | Wilson-Cook Medical, Inc. | 2017 | — |
| +1 | K241801 | Tornus ES | Asahi Intecc Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K851960 | Soehendra Biliary Dilating Catheter-SBDC-7Summary page 4…BDC) Geenen® Graduated Dilation Catheter (GGDC) Dilation Catheter Biliary Catheter and Accessories 21 CFR §876.5010; FGE Class II Soehendra® Biliary Dilation Catheter, K851960, cleared April 18, 1985 Vennes® Pancreatic Dilation Set, K851956, cleared June 13, 1985 The Cotton® Graduated Dilation Catheter,… | 1985 |
| * | K851956 | VPDS-1 Vennes Pancreatic Dilation SetSummary page 4…Biliary Catheter and Accessories 21 CFR §876.5010; FGE Class II Soehendra® Biliary Dilation Catheter, K851960, cleared April 18, 1985 Vennes® Pancreatic Dilation Set, K851956, cleared June 13, 1985 The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation… | 1985 |
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 |
|---|---|---|---|
| K241801 | Tornus ES | 2024 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K241801 (Asahi Intecc Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheters are used to dilate biliary strictures. These devices are indicated for adult use only.
The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.
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/K171548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171548: Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171548
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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