# K201007: In-Ka Ureteral Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Jun 11, 2020 after 55 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 K993840 (2000). 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)
- K993840: Bard Uroforce Balloon Dilation Catheter, C.R. Bard, Inc. (2000) Summary page 4.

## Indications for use
In-Ka ureteral balloon dilatation catheters are intended for: • Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures • Treatment of ureteral stenosis Target population Patients requiring endourologic procedures and/or presenting with ureteral stenosis. Duration of Use In-Ka ureteral balloon dilatation catheters are intended for transient use (less than 1 hour).

Source page: https://510kreport.com/device/K201007
Methodology: https://510kreport.com/methodology