# K143609: Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Mar 27, 2015 after 98 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 K974788 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 4.

## Most influential descendants
- K180086: Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (2018), 0 descendants of its own

## Indications for use
The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Source page: https://510kreport.com/device/K143609
Methodology: https://510kreport.com/methodology