510(k) · Cleared
Recalled · Class II · 2018Biliary Stent, Biliary Stent System, Biliary Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 30, 1997 as substantially equivalent to K834468 (Microvasive, 1984) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1984. 17 later devices descend from it. It has been recalled 23 times.
- Decided
- Jun 30, 1997
- Review
- 189 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 23
- Predicates
- 2
Its longest line of descent runs back 1 generation to K834468 (1984). 2 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK834468 Drainage StentMicrovasive · 1984 · Recalled
- This deviceK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997
- Descendant · cites it directly · 14 of its ownK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- Descendant · 2 generations on · 4 of its ownK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
- Descendant · 2 generations on · 3 of its ownK140630 Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK202477 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010 · cites it directly14descendants
- K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation · 2014 · 2 generations on4descendants
- K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020 · 2 generations on3descendants
- K140630Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · 2 generations on3descendants
- K202477EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| 0 (this device) | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | — |
| +1 | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| +2 | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… | Boston Scientific Corporation | 2014 | 13 |
| +2 | K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020 | — |
| +2 | K140630 | Wallflex Biliary RX Stent System | Boston Scientific | 2014 | 1 |
| +3 | K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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
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 |
|---|---|---|---|
| * | K834468 | Drainage StentSummary page 3…IMA™ BILIARY DRAINAGE CATHETER New Microvasive® Biliary i Solopass™ Percuflex i Fexima™ Biliary Stent and Delivery System Biliary Stent Drainage Catheter (This 510(k)) (K834468) (K944290) USE Indication Biliary Drainage «— Same «— Same Route of Administration Endoscopic «— Same ?:;fi::g;fi:; s STENT Type Am… | 1984 |
| * | K944290 | Catheters, Biliary Catheters, UrologicalSummary page 3…RY DRAINAGE CATHETER New Microvasive® Biliary i Solopass™ Percuflex i Fexima™ Biliary Stent and Delivery System Biliary Stent Drainage Catheter (This 510(k)) (K834468) (K944290) USE Indication Biliary Drainage «— Same «— Same Route of Administration Endoscopic «— Same ?:;fi::g;fi:; s STENT Type Amsterdam «—… | 1994 |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2018 | Class II | Z-1012-2019 | Other | The sterile barrier may contain packaging seal defects. |
| Dec 26, 2018 | Class II | Z-1013-2019 | Other | The sterile barrier may contain packaging seal defects. |
| Apr 27, 2010 | Not classified | Z-1979-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1994-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1984-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1977-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1975-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1991-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1983-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1981-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1985-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1993-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1988-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-197-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1976-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1980-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1992-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1990-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1982-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1986-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1989-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 27, 2010 | Not classified | Z-1987-2010 | Packaging | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Apr 2, 2008 | Not classified | Z-2105-2008 | Packaging process control | Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FGE devicesFGE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 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?
The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
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/K965147 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965147: Biliary Stent, Biliary Stent System, Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965147
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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