# K171043: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Dec 21, 2017 after 258 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: 1 generation back to K962004 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962004: AQ Hydrophilic Urological Catheters, Cook Urological, Inc. (1996) Summary page 4.

## Most influential descendants
- K182122: Ureteric Catheters (2018), 1 descendant of its own
- K192183: RocaTub Ureteral Catheter (2020), 0 descendants of its own

## Indications for use
Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline. Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

Source page: https://510kreport.com/device/K171043
Methodology: https://510kreport.com/methodology