510(k) · Cleared
ClearedZimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
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 Jun 14, 2024 as substantially equivalent to K172057 (Cook Ireland, Ltd., 2018) after a 262-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jun 14, 2024
- Review
- 262 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900923 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK900923 Zimmon Endoscopic Pancreatic StentWilson-Cook Medical, Inc. · 1990
- 1 generation backK172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent…Cook Ireland, Ltd. · 2018
- This deviceK233079 Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS…Cook Ireland, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900923 | Zimmon Endoscopic Pancreatic Stent | Wilson-Cook Medical, Inc. | 1990 | — |
| −1 | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets… | Cook Ireland, Ltd. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…Summary page 6…ntial Page 2 of 5 III. PREDICATE DEVICE Predicate: Pancreatic Stents & Sets cleared under K172057 IV. DEVICE DESCRIPTION The intended use of all Cook pancreatic stents and sets is to drain pancreatic ducts. A variety o… | 2018 |
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 34 years and passes through 2 companies; a new generation was cleared every 27.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K172057.
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. 2024, 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?
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF): Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic…
Read the full statement (202 words)
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF):
Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.
Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS):
Endoscopic pancreatic stent placement for pancreatic drainage of obstructed ducts that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, and disrupted duct.
Pushing Catheter and Guiding Catheter (GC, PC):
These devices are indicated for use with biliary and pancreatic stents for the following indications.
For endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction and benign or malignant strictures.
For endoscopic pancreatic stent placement for pancreatic duct drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula / pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233079: Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233079
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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