510(k) · Decided

Decided

Dynalink Biliary Self-Expanding Stent System

K002143510(k) TraditionalDecided Oct 12, 200087-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Guidant Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Oct 12, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided: Oct 12, 2000
Review: 87 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 0

17 later devices descend from it, 4 citing it directly.

This deviceK002143 Dynalink Biliary Self-Expanding Stent SystemGuidant Corp. · 2000
Descendant · cites it directly · 8 of its ownK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
Descendant · 2 generations on · 7 of its ownK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
Descendant · cites it directly · 5 of its ownK011881 Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2001
Descendant · 2 generations on · 4 of its ownK014184 Modification to Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2002
Descendant · 3 generations on · 3 of its ownK033393 Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2001high 3 (2002) · low 0 (2006)2026

Most influential descendants

Showing 5 of 17 · See all

K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810Jomed AG · 2003 · cites it directly8descendants
K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Abbott Laboratories · 2003 · 2 generations on7descendants
K011881Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2001 · cites it directly5descendants
K014184Modification to Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2002 · 2 generations on4descendants
K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002143	Dynalink Biliary Self-Expanding Stent System	Guidant Corp.	2000	—
+1	K030053	Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808…	Jomed AG	2003	—
+2	K033537	Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006…	Abbott Laboratories	2003	—
+1	K011881	Dynalink .035 Biliary Self-Expanding Stent System	Guidant Corp.	2001	—
+2	K014184	Modification to Dynalink .035 Biliary Self-Expanding Stent System	Guidant Corp.	2002	—
+3	K033393	Absolute .035 Self-Expanding Biliary Stent System	Guidant Corp.	2003	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	3	0
2003	3	0
2004	3	0
2005	1	0
2008	3	0
2010	1	0
2012	1	0
2026	1	0

FIG. 1 — Lineage of K002143, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030053	Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810	Jomed AG	2003	8
K011881	Dynalink .035 Biliary Self-Expanding Stent System	Guidant Corp.	2001	5
K072301	5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05	Ev3, Inc.	2008	2
K014007	Dynalink .018 Billary Self-Expanding Stent System	Guidant Corp.	2002	1

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, K030053 (Jomed AG, 2003) has gone furthest, with 8 descendants of its own.

How does its category compare?

All FGE devices

FGE 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

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)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	—

https://510kreport.com/device/K002143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002143: Dynalink Biliary Self-Expanding Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002143

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026