510(k) · Cleared
ClearedKarl Storz Uretero-Renoscope/Ureterscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Jun 24, 1994 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 24, 1994
- Review
- 142 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK940464 Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK963855 12 Ureteroscopes/Uretero-RenoscopesRichard Wolf Medical Instruments Corp. · 1997
- Descendant · cites it directly · 1 of its ownK233372 KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK253411 Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025
- Descendant · 2 generations on · 0 of its ownK991178 Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac…Richard Wolf Medical Instruments Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK990050 Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042Richard Wolf Medical Instruments Corp. · 1999
Most influential descendants
Showing 5 of 5 · See all- K96385512 Ureteroscopes/Uretero-RenoscopesRichard Wolf Medical Instruments Corp. · 1997 · cites it directly2descendants
- K233372KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG · 2024 · cites it directly1descendant
- K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025 · cites it directly0descendants
- K991178Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253Richard Wolf Medical Instruments Corp. · 1999 · 2 generations on0descendants
- K990050Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042Richard Wolf Medical Instruments Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940464 | Karl Storz Uretero-Renoscope/Ureterscope | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| +1 | K963855 | 12 Ureteroscopes/Uretero-Renoscopes | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +1 | K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG | 2024 | 14 |
| +1 | K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | 2025 | — |
| +2 | K991178 | Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece… | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +2 | K990050 | Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042 | Richard Wolf Medical Instruments Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K963855 (Richard Wolf Medical Instruments Corp., 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K940464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940464: Karl Storz Uretero-Renoscope/Ureterscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940464
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026