# K170531: Ureteral Dilators and Percutaneous Nephrostomy Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Aug 17, 2017 after 176 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K250448: Disposable Percutaneous Nephrostomy Dilatation Kit (2025), 0 descendants of its own

## Recalls of this device
- Mar 11, 2024 · Class II · Z-1463-2024: A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified

## Indications for use
Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures. Percutaneous Nephrostomy Dilators: Dilator for tract preparation or splittable working sheath to protect the parenchyma.

Source page: https://510kreport.com/device/K170531
Methodology: https://510kreport.com/methodology