510(k) · Cleared
ClearedAdvanix Biliary Stent with Naviflex RX Delivery System
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 Jul 23, 2010 as substantially equivalent to K965147 (Boston Scientific Corp, 1997) after a 73-day review. Its family tree reaches back 2 generations to 1984. 14 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 73 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K834468 (1984). 3 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 1 generation backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- This deviceK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 4 of its ownK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK140630 Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK202477 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020
- Descendant · 2 generations on · 1 of its ownK243412 ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation · 2014 · cites it directly4descendants
- K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020 · cites it directly3descendants
- K140630Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · cites it directly3descendants
- K202477EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020 · 2 generations on2descendants
- K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −1 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| 0 (this device) | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| +1 | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… | Boston Scientific Corporation | 2014 | 13 |
| +1 | K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020 | — |
| +1 | K140630 | Wallflex Biliary RX Stent System | Boston Scientific | 2014 | 1 |
| +2 | K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020 | — |
| +2 | K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025 | — |
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 |
|---|---|---|
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | K965147 | Biliary Stent, Biliary Stent System, Biliary EndoprosthesisSummary page 1…lass 11 3. Predicate Device: Trade Name: Microvasiveg Biliary Sternt and Delivery System Manufacturer and Clearance Number: Boston Scientific Corporation, K965 147- Classification Name: Biliary Catheters and Accessories Regulation Number: 876.50 10 Product Code: FOE… | 1997 |
What descends from it? (14)
See all 144 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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K133700 (Boston Scientific Corporation, 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K965147.
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. 2010, this device’s year, is highlighted.
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?
AdvanixTM Biliary Stent with NaviFlexTM RX 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 as stated in the FDA summary.
https://510kreport.com/device/K101314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101314: Advanix Biliary Stent with Naviflex RX Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101314
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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