510(k) · Cleared
ClearedWallstent Enteral Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · MUM Stent, Metallic, Expandable, Duodenal
Cleared on Apr 3, 1998 after an 80-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Apr 3, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- MUM
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly.
- This deviceK980113 Wallstent Enteral EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · cites it directly · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · 2 generations on · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 3 generations on · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- Descendant · 4 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · cites it directly40descendants
- K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · 2 generations on37descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · 3 generations on11descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980113 | Wallstent Enteral Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +1 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +2 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| +3 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +3 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| +4 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 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 MUM? 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 MUM device
- #1 K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic…score 10.9 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | WALLSTENT® Enteral Endoprosthesis Named without a submission number |
What descends from it? (47)
See all 472 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, K982184 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 40 descendants of its own.
How does its category compare?
All MUM devicesMUM Stent, Metallic, Expandable, Duodenal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUM
Too few MUM 510(k)s in any year since 2007 to give a median.
Recalls per year · MUM
No recall names MUM since 2007.
Adverse event reports per year · MUM
32in 2025
MAUDE reports naming product code MUM, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 102 |
| 2011 | 1 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 71 |
| 2013 | 0 | — | 0 | 62 |
| 2014 | 0 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 41 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 70 |
| 2022 | 0 | — | 0 | 28 |
| 2023 | 1 | — | 0 | 53 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant 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/K980113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980113: Wallstent Enteral Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980113
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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