510(k) · Decided
DecidedBlack Silicone Filiform Double Pigtail 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 Mar 26, 2018 as substantially equivalent to K161236 (Cook Incorporated, 2017) after a 266-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Mar 26, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903345 (1991). 8 ancestors in all, the oldest K905289 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 5 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 4 generations backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- 3 generations backK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- 1 generation backK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- This deviceK172017 Black Silicone Filiform Double Pigtail Stent SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −5 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −4 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| −3 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| −2 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| −1 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| 0 (this device) | K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K161236 | Universa Firm Ureteral Stents and Stent SetsSummary page 4…II Classification Panel: Gastroenterology/Urology Predicate Device: The predicate device is Universa™ Firm Ureteral Stents and Stent Sets, cleared under 510(k) K161236 on January 27, 2017. Device Description: The Black Silicone Filiform Double Pigtail Stent Set is a sterile, single-use device.… | 2017 |
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 27 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161236.
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?
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172017: Black Silicone Filiform Double Pigtail 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/K172017
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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