510(k) Report

510(k) · Cleared

Cleared

Zimmon Endoscopic Pancreatic Stent

K900923510(k) TraditionalCleared Oct 26, 1990241-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

Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Oct 26, 1990 after a 241-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Oct 26, 1990
Review
241 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
0

10 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK900923 Zimmon Endoscopic Pancreatic StentWilson-Cook Medical, Inc. · 1990
  2. Descendant · cites it directly · 4 of its ownK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
  3. Descendant · cites it directly · 2 of its ownK172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent…Cook Ireland, Ltd. · 2018
  4. Descendant · 2 generations on · 1 of its ownK243412 ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025
  5. Descendant · 2 generations on · 1 of its ownK223592 Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX)…Boston Scientific Corporation · 2022 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK260835 ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003: 12014: 12017: 12018: 12022: 12024: 12025: 22026: 2
2003high 2 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all
  • K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation · 2014 · cites it directly4descendants
  • K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…Cook Ireland, Ltd. · 2018 · cites it directly2descendants
  • K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025 · 2 generations on1descendant
  • K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific Corporation · 2022 · 2 generations on1descendant
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900923Zimmon Endoscopic Pancreatic StentWilson-Cook Medical, Inc.1990—
+1K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery…Boston Scientific Corporation201413
+1K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets…Cook Ireland, Ltd.2018—
+2K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2025—
+2K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic…Boston Scientific Corporation20221
+3K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201410
201710
201810
202210
202410
202520
202620
FIG. 1 — Lineage of K900923, 1990–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation20144
K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…Cook Ireland, Ltd.20182
K171623Nasal Pancreatic Drainage SetCook Ireland, Ltd.20170
K021672Pancreatic Drainage TubeAomori Olympus Co., Ltd.20030

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?

  • Of its descendants, K133700 (Boston Scientific Corporation, 2014) has gone furthest, with 4 descendants of its own.

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.

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—

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 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/K900923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900923: Zimmon Endoscopic Pancreatic Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900923

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026