# K192183: RocaTub Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Promepal Sam
- Decided: Apr 23, 2020 after 255 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: 3 generations back to K950300 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182122: Ureteric Catheters, Coloplast Corp. (2018) Summary page 4.

## Indications for use
The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.

Source page: https://510kreport.com/device/K192183
Methodology: https://510kreport.com/methodology