510(k) · Decided
DecidedModification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 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 Jun 28, 2002 after a 60-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 28, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK021345 Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on…Cordis Corp. · 2002
- Descendant · cites it directly · 2 of its ownK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
- Descendant · 2 generations on · 1 of its ownK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
- Descendant · cites it directly · 1 of its ownK051785 Formula 418 Biliary StentCook, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK063481 Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK052539 Cook Formula 418 Biliary Stent SystemCook, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2004 · cites it directly2descendants
- K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006 · 2 generations on1descendant
- K051785Formula 418 Biliary StentCook, Inc. · 2005 · cites it directly1descendant
- K063481Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007 · 3 generations on0descendants
- K052539Cook Formula 418 Biliary Stent SystemCook, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021345 | Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom… | Cordis Corp. | 2002 | — |
| +1 | K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2004 | — |
| +2 | K053454 | RX Herculink Elite Biliary Stent System | Guidant Corporation | 2006 | — |
| +1 | K051785 | Formula 418 Biliary Stent | Cook, Inc. | 2005 | — |
| +3 | K063481 | Modification to RX Herculink Elite Biliary Stent System | Abbott Vascular, Inc. | 2007 | — |
| +1 | K052539 | Cook Formula 418 Biliary Stent System | Cook, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | — | PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018” Delivery System Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K040413 (Cordis Europa, N.V., 2004) has gone furthest, with 2 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 PALMAZ@ GENESISTMTranshepatic Biliary Stent on SLALOMTM .018” Delivery System is intended for the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021345: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021345
Report an extraction error
Are you the manufacturer?
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