510(k) · Cleared
ClearedStryker Flexible Ureteroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Oct 16, 2003 as substantially equivalent to K970427 (Karl Storz Endoscopy, 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 16, 2003
- Review
- 177 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970427 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970427 Ksea Uretero-Reno-Fiberscope and Nephro-FiberscopeKarl Storz Endoscopy · 1997
- This deviceK031278 Stryker Flexible UreteroscopeStryker Endoscopy · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970427 | Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope | Karl Storz Endoscopy | 1997 | — |
| 0 (this device) | K031278 | Stryker Flexible Ureteroscope | Stryker Endoscopy | 2003 | — |
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 FGB? 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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 |
|---|---|---|---|
| * | K970427 | Ksea Uretero-Reno-Fiberscope and Nephro-FiberscopeSummary page 1…er Flexible Ureteroscope is substantially equivalent in safety and efficacy to the currently marketed Karl Storz Uretero Fiberscope (KSEAI 1273) as cleared under 510(k) #K970427. The Stryker Flexible Ureteroscope is a newly marketed product for Stryker Endoscopy and is based upon technology used in endosc… | 1997 |
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.
- 1 other device also cites its predicate K970427.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The Stryker Flexible Ureteroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices and is intended for, but not limited to transurethral examination of the upper urinary tract including the ureter, and kidney and, utilizing additional accessories for various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031278: Stryker Flexible Ureteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031278
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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