# K040127: Cook Ureteral Balloon Dilation Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Apr 6, 2004 after 76 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 K813278 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813278: Vpi Ureteral Dilatation Ballon Catheter, Vance Products, Inc. (1981) Summary page 1.
- K905375: Accent DG Balloon Ureteral Dilator Set, Cook Urological, Inc. (1991) Summary page 1.
- K970041: Ascend Balloon Dailation Catheter, Cook Urological, Inc. (1997) Summary page 1.
- (no number) Balloon Dilation Catheters: named in the summary without a submission number
- (no number) High Pressure Ureteral Dilatation Balloon Catheter: named in the summary without a submission number

## Indications for use
The Cook Ureteral Balloon Dilation Catheter Set is used for Dilation prior to stone manipulation or ureteroscopy, and Dilating the intramural ureter. This device is sterile And intended for one-time use.

Source page: https://510kreport.com/device/K040127
Methodology: https://510kreport.com/methodology