# K172057: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Mar 9, 2018 after 246 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: 1 generation back to K900923 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900923: Zimmon Endoscopic Pancreatic Stent, Wilson-Cook Medical, Inc. (1990) Summary page 5.
- K990130: Wilson-Cook Pancreatic Wedge Stent, Wilson-Cook Medical, Inc. (1999) Summary page 5.

## Most influential descendants
- K251658: Endoflux™ Biliary & Pancreatic Stent Sets (2026), 0 descendants of its own
- 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) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K172057
Methodology: https://510kreport.com/methodology