# K834468: Drainage Stent

- Pathway: 510(k) (Traditional)
- Applicant: Microvasive
- Decided: Apr 20, 1984 after 122 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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
- K965147: Biliary Stent, Biliary Stent System, Biliary Endoprosthesis (1997), 17 descendants of its own
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System (2010), 14 descendants of its own
- K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers (2014), 4 descendants of its own
- K193600: EndoGI Biliary Stent System (2020), 3 descendants of its own
- K140630: Wallflex Biliary RX Stent System (2014), 3 descendants of its own

## Recalls of this device
- Jun 18, 2004 · Not classified · Z-1103-04: Mislabeled as to length; 5 cm length labeled as 10 cm.
- Jun 18, 2004 · Not classified · Z-1102-04: Mislabeled as to length; 10 cm length labeled as 5 cm.

Source page: https://510kreport.com/device/K834468
Methodology: https://510kreport.com/methodology