PMA · Approved
ApprovedGORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MIR Shunt, Portosystemic, Endoprosthesis
Approved on Sep 12, 2024 through premarket approval, which rests on the device’s own clinical evidence after a 9-day review.
- Decided
- Sep 12, 2024
- Review
- 9 days
- Class
- Class III
- Product code
- MIR
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All MIR devicesMIR Shunt, Portosystemic, Endoprosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MIR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MIR
Too few MIR 510(k)s in any year since 2007 to give a median.
Recalls per year · MIR
No recall names MIR since 2007.
Adverse event reports per year · MIR
16in 2025
MAUDE reports naming product code MIR, 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 | — | 0 | 1 |
| 2008 | 6 | — | 0 | 4 |
| 2009 | 6 | — | 0 | 6 |
| 2010 | 5 | — | 0 | 8 |
| 2011 | 6 | — | 0 | 7 |
| 2012 | 10 | — | 0 | 9 |
| 2013 | 16 | — | 0 | 11 |
| 2014 | 7 | — | 0 | 8 |
| 2015 | 9 | — | 0 | 6 |
| 2016 | 9 | — | 0 | 8 |
| 2017 | 8 | — | 0 | 13 |
| 2018 | 10 | — | 0 | 20 |
| 2019 | 11 | — | 0 | 29 |
| 2020 | 8 | — | 0 | 14 |
| 2021 | 7 | — | 0 | 13 |
| 2022 | 6 | — | 0 | 23 |
| 2023 | 4 | — | 0 | 22 |
| 2024 | 6 | — | 0 | 40 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P040027/S097 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040027/S097: GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040027/S097
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026