510(k) · Cleared

Cleared

Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis

K961262510(k) TraditionalCleared May 10, 199638-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

Boston Scientific Scimed, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on May 10, 1996 as substantially equivalent to K911292 (Pfizer Hospital Products Group, Inc., 1991) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1991. 55 later devices descend from it.

Decided: May 10, 1996
Review: 38 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K911292 (1991). 3 ancestors in all. 55 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
This deviceK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
Descendant · cites it directly · 54 of its ownK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
Descendant · cites it directly · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
Descendant · cites it directly · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
Descendant · 2 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
Descendant · 2 generations on · 14 of its ownK993232 Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

1997high 5 (1999) · low 0 (2004)2026

Most influential descendants

Showing 5 of 55 · See all

K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · cites it directly54descendants
K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · cites it directly40descendants
K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · cites it directly37descendants
K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 2 generations on23descendants
K993232Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911292	Schneider Wallstent (R)	Pfizer Hospital Products Group, Inc.	1991	—
0 (this device)	K961262	Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary…	Boston Scientific Scimed, Inc.	1996	—
+1	K964119	Wallstent Transhepatic Biliary Endoprosthesis	Boston Scientific Scimed, Inc.	1997	6
+1	K982184	Wallstent Endoprosthesis	Boston Scientific Scimed, Inc.	1998	—
+1	K012752	Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive	Boston Scientific Corp	2001	1
+2	K073667	Niti-S Biliary Stent	Taewoong Medical Co., Ltd.	2008	—
+2	K993232	Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System	Boston Scientific Scimed, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	3	0
1999	5	0
2000	1	0
2001	2	0
2002	2	0
2003	2	0
2006	3	0
2008	2	0
2009	3	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	3	0
2015	1	0
2018	1	0
2019	1	0
2020	2	0
2021	3	0
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K961262, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K911292	Schneider Wallstent (R) Summary page 1 …is, MN 55442 (612) 550-5848 Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Eiliary Transhepatic Endoprosthesis WALLSTENT® Eiliary Endoscopic Endoprosthesis K911292, K914277, K923993 T e v o TruwvToT Il L P 2 TIZTACNR z Device Description The WALLSTENT® Biliary Endoprosthesis…	Pfizer Hospital Products Group, Inc.	1991	—
*	K914277	Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY Summary page 1 …442 (612) 550-5848 Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Eiliary Transhepatic Endoprosthesis WALLSTENT® Eiliary Endoscopic Endoprosthesis K911292, K914277, K923993 T e v o TruwvToT Il L P 2 TIZTACNR z Device Description The WALLSTENT® Biliary Endoprosthesis is a sel…	Schneider U.S. Stent Div.	1991	—
*	K923993	Wallstent Biliary Endoprotheses Summary page 1 …550-5848 Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Eiliary Transhepatic Endoprosthesis WALLSTENT® Eiliary Endoscopic Endoprosthesis K911292, K914277, K923993 T e v o TruwvToT Il L P 2 TIZTACNR z Device Description The WALLSTENT® Biliary Endoprosthesis is a self-expandi…	Schneider U.S. Stent Div.	1994	—

Also cleared against K911292: 3 other devices →

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K964119	Wallstent Transhepatic Biliary Endoprosthesis	Boston Scientific Scimed, Inc.	1997	54
K982184	Wallstent Endoprosthesis	Boston Scientific Scimed, Inc.	1998	40
K012752	Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive	Boston Scientific Corp	2001	37
K980653	Perflex Stainless Steel Stent and Delivery System	Cordis Corp.	1998	7
K081956	Medinol X-Suit Nir Biliary Metallic Stent	Medinol, Ltd.	2009	0
K982005	Wallstent Transhepatic Biliary Endoprosthesis	Boston Scientific Scimed, Inc.	1998	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 3 ancestors has a recall.
Of its descendants, K964119 (Boston Scientific Scimed, Inc., 1997) has gone furthest, with 54 descendants of its own.
3 other devices also cite its predicate K911292.

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	—

What is it indicated for?

for treatment of bilary strictures produced by malighant neoplasms.

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/K961262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961262

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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