# K143303: Single Use Biliary Balloon Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Feb 27, 2015 after 101 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: 2 generations back to K920361 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050502: Single Use Balloon Dilator Maxpasstm, Olympus Winter & Ibe GmbH (2005) Summary page 5.

## Indications for use
Single use balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.

Source page: https://510kreport.com/device/K143303
Methodology: https://510kreport.com/methodology