# K171603: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 16, 2018 after 319 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K924608 (1994). 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)
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System, Boston Scientific Corp (2014) Summary page 5.
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 5.

## Indications for use
The Cope Nephroureterostomy Stent is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. The Cope Nephroureterostomy Stents are not intended to remain indwelling more than 90 days. The Amplatz Ureteral Stent Set is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Amplatz Ureteral Stents are not intended to remain indwelling more than 180 days.

Source page: https://510kreport.com/device/K171603
Methodology: https://510kreport.com/methodology