510(k) · Cleared
ClearedEndoGI S-Path Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo GI Medical · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 24, 2020 as substantially equivalent to K193600 (Endogi Medical, Ltd., 2020) after a 27-day review. Its family tree reaches back 4 generations to 1984. 2 later devices descend from it.
- Decided
- Sep 24, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K834468 (1984). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 3 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- 2 generations backK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- 1 generation backK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
- This deviceK202477 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −3 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| −2 | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| −1 | K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020 | — |
| 0 (this device) | K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K193600 | EndoGI Biliary Stent SystemSummary page 4…eview Panel: Gastroenterology/Urology III. PREDICATE DEVICES Predicate device EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K193600. IV. DEVICE DESCRIPTION The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one… | 2020 |
What descends from it? (2)
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 4 companies; a new generation was cleared every 13.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K222627 (Endo GI Medical, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K193600.
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 S-Path 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/K202477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202477: EndoGI S-Path 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/K202477
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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