510(k) Report

510(k) · Decided

Decided

EndoGI S-Path Biliary Stent System

K232596510(k) SpecialDecided Sep 27, 202333-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endogi Medical, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Sep 27, 2023 as substantially equivalent to K222627 (Endo GI Medical, 2022) and 2 other predicates after a 33-day review. Its family tree reaches back 6 generations to 1984.

Decided
Sep 27, 2023
Review
33 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K834468 (1984). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK834468 · Drainage Stent · Microvasive · 1984 · recalledK965147 · Biliary Stent, Biliary Stent System, Biliary Endoprosthesis · Boston Scientific Corp · 1997 · recalledK101314 · Advanix Biliary Stent with Naviflex RX Delivery System · Boston Scientific Corp · 2010×2: 2 generations cleared close together, K193600 (2020), K202477 (2020) K222627 · EndoGI S-Path Biliary Stent System · Endo GI Medical · 202219801990200020102020
Other ancestors, by generation 4 generations back: 1 other ancestor K222627 · EndoGI S-Path Biliary Stent System · Endo GI Medical · 2022K202477 · EndoGI S-Path Biliary Stent System · Endo GI Medical · 2020K193600 · EndoGI Biliary Stent System · Endogi Medical, Ltd. · 2020K101314 · Advanix Biliary Stent with Naviflex RX Delivery System · Boston Scientific Corp · 2010K965147 · Biliary Stent, Biliary Stent System, Biliary Endoprosthesis · Boston Scientific Corp · 1997 · recalledK834468 · Drainage Stent · Microvasive · 1984 · recalled−50
  1. Root · 6 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
  2. 5 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
  3. 4 generations backK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
  4. 3 generations backK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
  5. 2 generations backK202477 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2020
  6. 1 generation backK222627 EndoGI S-Path Biliary Stent SystemEndo GI Medical · 2022
  7. This deviceK232596 EndoGI S-Path Biliary Stent SystemEndogi Medical, Ltd. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K834468Drainage StentMicrovasive19842
−5K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp199723
−4K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp2010—
−3K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd.2020—
−2K202477EndoGI S-Path Biliary Stent SystemEndo GI Medical2020—
−1K222627EndoGI S-Path Biliary Stent SystemEndo GI Medical2022—
0 (this device)K232596EndoGI S-Path Biliary Stent SystemEndogi Medical, Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K232596, 1984–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K222627EndoGI S-Path Biliary Stent System
Summary page 5
…Review Panel: Gastroenterology/Urology 3. PREDICATE DEVICES Predicate device EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K222627, K202477 and K193600. 4. DEVICE DESCRIPTION The revised EndoGI S-Path System incorporates one preloaded stent which has a s…
Endo GI Medical2022—
*K202477EndoGI S-Path Biliary Stent System
Summary page 5
…nel: Gastroenterology/Urology 3. PREDICATE DEVICES Predicate device EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K222627, K202477 and K193600. 4. DEVICE DESCRIPTION The revised EndoGI S-Path System incorporates one preloaded stent which has a straight b…
Endo GI Medical2020—
*K193600EndoGI Biliary Stent System
Summary page 5
…nterology/Urology 3. PREDICATE DEVICES Predicate device EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K222627, K202477 and K193600. 4. DEVICE DESCRIPTION The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one…
Endogi Medical, Ltd.2020—

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.

What does this lineage say?

  • The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
  • 3 of the 7 ancestors have a recall of any class.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

The EndoGl 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Endogi Medical, Ltd.

2 FDA decisions under this applicant name. See the company

  • K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K232596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232596: 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/K232596

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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