510(k) · Decided
DecidedCope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FAD Stent, Ureteral
Cleared on Apr 16, 2018 as substantially equivalent to K141344 (Boston Scientific Corp, 2014) and 1 other predicate after a 319-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 16, 2018
- Review
- 319 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924608 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- 1 generation backK141344 Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel…Boston Scientific Corp · 2014
- This deviceK171603 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| −1 | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral… | Boston Scientific Corp | 2014 | — |
| 0 (this device) | K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…Summary page 5…: Gastroenterology/Urology Predicate Devices: Expel™ Nephroureteral Drainage Stent with Twist-Loc Hub System and the Expel™ Ureteral Drainage Stent System (K141344), cleared for market by FDA on October 17, 2014, and the Percuflex Nephroureteral Stent (K924608), cleared for market on January… | 2014 |
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 5…with Twist-Loc Hub System and the Expel™ Ureteral Drainage Stent System (K141344), cleared for market by FDA on October 17, 2014, and the Percuflex Nephroureteral Stent (K924608), cleared for market on January 26, 1994. Device Description: The Cope Nephroureterostomy Stent is an internal/external drainin… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K141344.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171603: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026