# K161203: Soehendra Stent Retriever

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: May 4, 2016 after 6 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 K903420 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903420: Soehendra Stent Retriever, Wilson-Cook Medical, Inc. (1990) Summary page 4.

## Indications for use
Used to remove stents from the biliary and pancreatic duct(s) while maintaining wire guide placement

Source page: https://510kreport.com/device/K161203
Methodology: https://510kreport.com/methodology