# K183323: UPJ Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 5, 2019 after 248 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K841941 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133750: Occluder Occlusion Balloon Catheter, Boston Scientific Corporation (2014) Summary page 4.

## Indications for use
Used to temporarily occlude the ureteropelvic junction to prevent stone fragments from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.

Source page: https://510kreport.com/device/K183323
Methodology: https://510kreport.com/methodology