# K990072: Balloon Ureteral Dilators, Accent DG Balloon Ureteral Dilator Set, Ascend Balloon Dilation Catheters, Balloon Dilation C

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 25, 1999 after 73 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Balloon Dilation Catheters manufactured by Bard: named in the summary without a submission number
- (no number) High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive: named in the summary without a submission number
- (no number) Balloon Dilation Catheters from Cook Urological, Inc.: named in the summary without a submission number

## Recalls of this device
- Jan 22, 2003 · Not classified · Z-0554-03: Product is labeled sterile, but was not sterilized.
- Jan 22, 2003 · Not classified · Z-0555-03: Product is labeled sterile, but was not sterilized.

## Indications for use
The device is intended for ureteral dilation prior to ureteral stone manipulation, ureteroscopy, and dilating the intramural ureter.

Source page: https://510kreport.com/device/K990072
Methodology: https://510kreport.com/methodology