# K173654: Ureteral Dilator Sets, Ureteral Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 17, 2018 after 231 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: 1 generation back to K961904 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961904: AQ Hydrophilic Dilators, Cook Urological, Inc. (1996) Summary page 4.

## Indications for use
The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation. The Ureteral Dilators are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.

Source page: https://510kreport.com/device/K173654
Methodology: https://510kreport.com/methodology