510(k) · Cleared
ClearedEndoGI Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endogi Medical, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 26, 2020 as substantially equivalent to K101314 (Boston Scientific Corp, 2010) after a 186-day review. Its family tree reaches back 3 generations to 1984. 3 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 186 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K834468 (1984). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 2 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- 1 generation backK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- This deviceK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK202477 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020
- Descendant · 2 generations on · 1 of its ownK222627 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2022
- Descendant · cites it directly · 0 of its ownK232596 EndoGI S-Path Biliary Stent SystemEndogi Medical, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −2 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| −1 | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020 | — |
| +1 | K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020 | — |
| +2 | K222627 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2022 | — |
| +1 | K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K101314 | Advanix Biliary Stent with Naviflex RX Delivery SystemSummary page 4…y 3 PREDICATE DEVICE Primary predicate device: • AdvaniX™ Biliary Stent with NaviFleX™ RX Delivery System, manufactured by Boston Scientific, cleared under K101314; Product Code: FGE. Reference device: • Marathon Stent with Fusion Technology, manufactured by Cook Ireland, cleared u… | 2010 |
| † | K060624 | Marathon Stent with Fusion Technology | 2006 |
What descends from it? (3)
2 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 36 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K202477 (Endo GI Medical, 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K101314.
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. 2020, 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?
The EndoGI Biliary Stent System is intended for delivery of stent(s) 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/K193600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193600: EndoGI Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193600
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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