# K132181: Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Oct 21, 2013 after 98 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- 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 K952968 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130804: Uromax Ultra Balloon Dilatation Catheter, Boston Scientific Corporation (2013) Summary page 1.

## Indications for use
The Cyrus ACMI Urn - EZ~ilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

Source page: https://510kreport.com/device/K132181
Methodology: https://510kreport.com/methodology