510(k) · Cleared
ClearedWallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · MQR Stent, Colonic, Metallic, Expandable
Cleared on Mar 8, 2024 as substantially equivalent to K201159 (Boston Scientific Corporation, 2020) and 1 other predicate after a 78-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Mar 8, 2024
- Review
- 78 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K000281 (2000). 14 ancestors in all, the oldest K954290 (1996). No later device cites it as a predicate yet.
- Root · 7 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 6 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 5 generations backK062750 Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System…Boston Scientific Corp · 2006
- 4 generations backK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
- 3 generations backK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- 2 generations backK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
- 1 generation backK200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2020
- This deviceK234046 WallFlex Colonic Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −6 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −5 | K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models… | Boston Scientific Corp | 2006 | — |
| −4 | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… | Cook Ireland, Ltd. | 2011 | — |
| −3 | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| −2 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
| −1 | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex… | Boston Scientific Corporation | 2020 | — |
| 0 (this device) | K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex… | Boston Scientific Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2020 | 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 MQR? 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 MQR device
- #1 K200257 WallFlex Colonic Soft Stent System with Anchor…score 3.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemSummary page 5….3610 Product Code(s) MQR,MUM | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201159 Wallflex Colonic Stent System with Anchor Lock Delivery Systerg( | MQR, MUM K200257 WallFlex Colonic Soft Stent System with Ancho… | 2020 |
| * | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Summary page 5…(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201159 Wallflex Colonic Stent System with Anchor Lock Delivery Systerg( | MQR, MUM K200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery §y| | MQR, MUM Device Description Summary 21 CFR 807.92(a)(4) The W… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 14 ancestors have a recall of any class.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQR
Too few MQR 510(k)s in any year since 2007 to give a median.
Recalls per year · MQR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQR
29in 2025
MAUDE reports naming product code MQR, 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 | 30 |
| 2008 | 0 | — | 0 | 144 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 1 | — | 0 | 104 |
| 2013 | 0 | — | 0 | 100 |
| 2014 | 0 | — | 0 | 70 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 1 | — | 0 | 44 |
| 2019 | 2 | — | 0 | 42 |
| 2020 | 2 | — | 0 | 46 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures. The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms. The WallFlex Colonic Soft…
Read the full statement (119 words)
The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Soft System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced 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/K234046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234046: WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock 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/K234046
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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