510(k) · Decided
DecidedCordis Nitinol Stent and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 18, 1998 after a 290-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 18, 1998
- Review
- 290 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK980823 Cordis Nitinol Stent and Delivery SystemCordis Corp. · 1998
- Descendant · cites it directly · 4 of its ownK031331 WZ Self-Expanding Stent Transhepatic Biliary SystemAbbott Vascular, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK032929 Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary…Abbott Vascular, Inc. · 2003
- Descendant · 3 generations on · 2 of its ownK050103 Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005
- Descendant · 4 generations on · 1 of its ownK050501 Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary…Abbott Vascular Devices · 2005
- Descendant · 5 generations on · 0 of its ownK072708 Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008
Most influential descendants
Showing 5 of 5 · See all- K031331WZ Self-Expanding Stent Transhepatic Biliary SystemAbbott Vascular, Inc. · 2003 · cites it directly4descendants
- K032929Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models…Abbott Vascular, Inc. · 2003 · 2 generations on3descendants
- K050103Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005 · 3 generations on2descendants
- K050501Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Vascular Devices · 2005 · 4 generations on1descendant
- K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980823 | Cordis Nitinol Stent and Delivery System | Cordis Corp. | 1998 | — |
| +1 | K031331 | WZ Self-Expanding Stent Transhepatic Biliary System | Abbott Vascular, Inc. | 2003 | — |
| +2 | K032929 | Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent… | Abbott Vascular, Inc. | 2003 | — |
| +3 | K050103 | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System | Abbott Laboratories | 2005 | — |
| +4 | K050501 | Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System | Abbott Vascular Devices | 2005 | — |
| +5 | K072708 | Absolute Pro .035 Self-Expanding Stent System | Abbott Vascular-Vascular Solutions | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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? (6)
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 |
|---|---|---|---|
| * | — | Wallstent® Biliary Endoprosthesis with Unistep™ Delivery System Named without a submission number | |
| * | — | Symphony™ Nitinol Stent Transhepatic Biliary System Named without a submission number | |
| * | — | Bard® Memotherm® Nitinol Stent Transhepatic Biliary Endoprosthesis Named without a submission number | |
| * | — | PALMAZ™ Balloon-Expandable Stent Named without a submission number | |
| * | — | PALMAZ™ & PALMAZ-SCHATZ™ Balloon-Expandable Stent and Stent Delivery Systems Named without a submission number | |
| * | — | Long Medium PALMAZ-SCHATZ™ Balloon-Expandable Stent Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031331 | WZ Self-Expanding Stent Transhepatic Biliary System | 2003 | 4 |
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, K031331 (Abbott Vascular, Inc., 2003) has gone furthest, with 4 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.
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 Cordis Nitinol Stent and Delivery System is intended for palliation of malignant neoplasms in the biliary tree.
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/K980823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980823: Cordis Nitinol Stent and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980823
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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