# K171810: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 7, 2018 after 261 days
- Product code: KOD (Catheter, Urological)
- 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 K760858 (1976). 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)
- K760858: Rutner Universal Wedge Catheter, Cook, Inc. (1976) Summary page 5.
- K870694: Van-Tec Open Ended Cone Tip Ureteral Catheter, Van-Tec, Inc. (1987) Summary page 5.

## Indications for use
The Cone Tip Ureteral Catheter is intended for retrograde pyelogram. The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.

Source page: https://510kreport.com/device/K171810
Methodology: https://510kreport.com/methodology