510(k) · Decided
DecidedPercuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FAD Stent, Ureteral
Cleared on Apr 26, 2021 as substantially equivalent to K924608 (Boston Scientific Corp, 1994) after a 448-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 26, 2021
- Review
- 448 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924608 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- This deviceK200260 Percuflex Ureteral Stent System, Percuflex Ureteral Stent System…Boston Scientific Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| 0 (this device) | K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit… | Boston Scientific Corporation | 2021 | — |
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 |
|---|---|---|---|
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 6…III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device Medi-Tech Ureteral Stent System, Nephroureteral Stent System, Amplatz Anchor System with Locking Malecot (K924608, Cleared 26-Jan-1994) Predicate devices referenced above have not been subject to a design-related recall. IV. DEVICE DESCRIPTI… | 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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K924608.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Ureteral Stent is intended to provide 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 Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.
The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200260 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200260: Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200260
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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