# K001222: Otw Megalink SDS Billiary Stent System, Models 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: May 17, 2000 after 30 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
- K030053: Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (2003), 8 descendants of its own
- K033537: Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005 (2003), 7 descendants of its own
- K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 (2008), 2 descendants of its own
- K040667: Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 (2004), 1 descendant of its own
- K033909: Wavemax Balloon-Expandable Transhepatic Biliary Stent System (2004), 1 descendant of its own

Source page: https://510kreport.com/device/K001222
Methodology: https://510kreport.com/methodology