510(k) · Cleared
Recalled · 2003Wallstent Enteral Endoprosthesis with Unistep Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MQR Stent, Colonic, Metallic, Expandable
Cleared on Jun 22, 1999 as substantially equivalent to K954290 (Boston Scientific Scimed, Inc., 1996) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- MQR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954290 (1996). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954290 Wallstent Enteral EndoprothesisBoston Scientific Scimed, Inc. · 1996
- This deviceK991056 Wallstent Enteral Endoprosthesis with Unistep Delivery SystemBoston Scientific Corp · 1999
- Descendant · cites it directly · 4 of its ownK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2020
- Descendant · 4 generations on · 0 of its ownK234046 WallFlex Colonic Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2024
Most influential descendants
Showing 5 of 5 · See all- K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DCook Ireland, Ltd. · 2011 · cites it directly4descendants
- K113510Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012 · 2 generations on3descendants
- K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd. · 2017 · 2 generations on2descendants
- K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation · 2020 · 3 generations on1descendant
- K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954290 | Wallstent Enteral Endoprothesis | Boston Scientific Scimed, Inc. | 1996 | — |
| 0 (this device) | K991056 | Wallstent Enteral Endoprosthesis with Unistep Delivery System | Boston Scientific Corp | 1999 | — |
| +1 | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… | Cook Ireland, Ltd. | 2011 | — |
| +2 | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| +2 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
| +3 | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex… | Boston Scientific Corporation | 2020 | — |
| +4 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 K234046 WallFlex Colonic Stent System with Anchor Lock…score 8.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K954290 | Wallstent Enteral EndoprothesisSummary page 1…NT® Enteral Endoprosthesis with Unistep™ Delivery System Classification: Class 111 Equivalent Devices: WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System, K954290 and K980113 Device Description: The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is composed of two componen… | 1996 |
| * | K980113 | Wallstent Enteral EndoprosthesisSummary page 1…Endoprosthesis with Unistep™ Delivery System Classification: Class 111 Equivalent Devices: WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System, K954290 and K980113 Device Description: The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is composed of two components: the impl… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2003 | Not classified | Z-1019-03 | Other | Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is indicated for palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
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/K991056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991056: Wallstent Enteral Endoprosthesis with Unistep 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/K991056
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