# K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Oct 8, 1999 after 88 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: 4 generations back to K911292 (1991). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983075: Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38, Guidant Corp. (1999) Summary page 1.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K980653: Perflex Stainless Steel Stent and Delivery System, Cordis Corp. (1998) Summary page 1.

## Most influential descendants
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own
- K053459: Omnilink .035 Biliary Stent System (2006), 0 descendants of its own

## Indications for use
The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of maligriant strictures in the biliary tree.

Source page: https://510kreport.com/device/K992319
Methodology: https://510kreport.com/methodology