# K182122: Ureteric Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Oct 4, 2018 after 59 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 K950300 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021856: Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX, Porges S.A. (2002) Summary page 4.
- K171043: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters, Coloplast Corp. (2017) Summary page 4.

## Most influential descendants
- K192183: RocaTub Ureteral Catheter (2020), 0 descendants of its own

## Indications for use
Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.

Source page: https://510kreport.com/device/K182122
Methodology: https://510kreport.com/methodology