# K882610: Cook-Gianturco Biliary Z Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Apr 21, 1989 after 301 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955728: Cordis Biliary Stent (1996), 8 descendants of its own
- K980653: Perflex Stainless Steel Stent and Delivery System (1998), 7 descendants of its own
- K991929: Intrastent (1999), 3 descendants of its own
- K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System (1999), 2 descendants of its own
- K993904: Intrastent Doublestrut LD (2000), 1 descendant of its own

Source page: https://510kreport.com/device/K882610
Methodology: https://510kreport.com/methodology