# K171662: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 1, 2018 after 241 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: 2 generations back to K950300 (1995). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K033719: Bard Tigertail Ureteral Catheter, C.R. Bard, Inc. (2004) Summary page 4.
- K021856: Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX, Porges S.A. (2002) Summary page 4.

## Most influential descendants
- K220036: Wellead Ureteral Catheter (2022), 0 descendants of its own
- K191187: Dornier MINNOW Ureteral Catheter (2019), 0 descendants of its own

## Indications for use
Ureteral catheters are indicated for access and catheterization of the urinary tract, including the following applications: • Delivery of contrast media • Drainage of fluids from the urinary tract • Delivery of irrigation fluids to the urinary tract • Navigation of a tortuous ureter • Access, advancement, or exchange of wire guides (open-ended catheters only) The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications: • Delivery of contrast media • Drainage of fluids from the urinary tract • Delivery of irrigation fluids to the urinary tract • Navigation of a tortuous ureter

Source page: https://510kreport.com/device/K171662
Methodology: https://510kreport.com/methodology