510(k) · Cleared
ClearedZimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 9, 2018 as substantially equivalent to K900923 (Wilson-Cook Medical, Inc., 1990) and 1 other predicate after a 246-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Mar 9, 2018
- Review
- 246 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900923 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900923 Zimmon Endoscopic Pancreatic StentWilson-Cook Medical, Inc. · 1990
- This deviceK172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent…Cook Ireland, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK251658 Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026
- Descendant · cites it directly · 0 of its ownK233079 Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS…Cook Ireland, Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −1 | K900923 | Zimmon Endoscopic Pancreatic Stent | Wilson-Cook Medical, Inc. | 1990 | — |
| 0 (this device) | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets… | Cook Ireland, Ltd. | 2018 | — |
| +1 | K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026 | — |
| +1 | K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF… | Cook Ireland, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K900923 | Zimmon Endoscopic Pancreatic StentSummary page 5…and Sets Page 8 of 227 Product Code: FGE III. PREDICATE DEVICE Cook Zimmon Endoscopic Pancreatic Stent cleared under 510(k): K900923 cleared on October 26, 1990 Wilson-Cook Pancreatic Wedge Stent (K990130 – cleared on February 12, 1999) IV. DEVICE DESCRI… | 1990 |
| * | K990130 | Wilson-Cook Pancreatic Wedge StentSummary page 5…: FGE III. PREDICATE DEVICE Cook Zimmon Endoscopic Pancreatic Stent cleared under 510(k): K900923 cleared on October 26, 1990 Wilson-Cook Pancreatic Wedge Stent (K990130 – cleared on February 12, 1999) IV. DEVICE DESCRIPTION The intended use of all Cook pancreatic stents is to drain obstr… | 1999 |
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?
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. 2018, 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?
Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.
This device is used to drain obstructed pancreatic ducts.
Stent Introducers: Guiding Catheter and Pushing Catheter.
This device is used for endoscopic pancreatic stent placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172057: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172057
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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