510(k) · Cleared
ClearedCotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 27, 2018 as substantially equivalent to K851962 (Wilson-Cook Medical, Inc., 1985) and 1 other predicate after a 236-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Feb 27, 2018
- Review
- 236 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851962 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK851962 Zimmon Biliary Stent SetWilson-Cook Medical, Inc. · 1985 · Recalled
- 1 generation backK040151 Oasis Biliary Stent Introduction SystemWilson-Cook Medical, Inc. · 2004
- This deviceK172044 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung…Cook Ireland, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK251658 Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026
- Descendant · cites it directly · 0 of its ownK230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary…Micro-Tech (Nanjing) Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213946 Compass BDS Biliary StentCook Ireland, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026 · cites it directly0descendants
- K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…Micro-Tech (Nanjing) Co., Ltd. · 2023 · cites it directly0descendants
- K213946Compass BDS Biliary StentCook Ireland, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851962 | Zimmon Biliary Stent Set | Wilson-Cook Medical, Inc. | 1985 | 5 |
| −1 | K040151 | Oasis Biliary Stent Introduction System | Wilson-Cook Medical, Inc. | 2004 | — |
| 0 (this device) | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex… | Cook Ireland, Ltd. | 2018 | — |
| +1 | K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026 | — |
| +1 | K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent… | Micro-Tech (Nanjing) Co., Ltd. | 2023 | — |
| +1 | K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K851962 | Zimmon Biliary Stent SetSummary page 7…theter and accessories (21 CFR 876.5010) Regulatory Class: II Product Code: FGE III. PREDICATE DEVICE Predicate: The Zimmon biliary stent set, cleared under K851962 on December 17, 1985 and the Oasis® one action introduction system, cleared under K040151 on February 20, 2004. IV. DEVICE… | 1985 |
| * | K040151 | Oasis Biliary Stent Introduction SystemSummary page 7…. PREDICATE DEVICE Predicate: The Zimmon biliary stent set, cleared under K851962 on December 17, 1985 and the Oasis® one action introduction system, cleared under K040151 on February 20, 2004. IV. DEVICE DESCRIPTION The intended use of all Cook biliary stents is to drain obstructed biliary duc… | 2004 |
What descends from it? (3)
3 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 33 years and passes through 2 companies; a new generation was cleared every 18.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K251658 (Medi-Globe GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K851962.
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. 2018, 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?
These devices are used to drain obstructed biliary ducts
The following devices are used for endoscopic biliary stent placement:
Guiding Catheter
Pushing Catheter
Fusion® Pushing catheter
Stent Introducer Set
The following devices (with preloaded stent , if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts:
Oasis® One Action Stent Introduction System
Fusion® Oasis® One Action Stent Introduction System
Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary stent.
Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.
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/K172044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172044: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172044
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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