# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Jun 14, 2024 after 262 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900923 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172057: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set, Cook Ireland, Ltd. (2018) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K233079
Methodology: https://510kreport.com/methodology