# K181669: ConvertX Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Brightwater Medical
- Decided: Mar 14, 2019 after 262 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: 3 generations back to K834468 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101786: Advanix Double Pigtail Biliary Stent, Boston Scientific Corp (2010) Summary page 4.
- K141335: Expel Apd Drainage Catheter System, Boston Scientific Corp (2014) Summary page 4.

## Indications for use
The ConvertX Biliary Stent System with releasable drainage catheter is delivered percutaneously and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the bile duct to the duodenum.

Source page: https://510kreport.com/device/K181669
Methodology: https://510kreport.com/methodology