510(k) · Cleared
ClearedUretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Mar 26, 1999 as substantially equivalent to K963855 (Richard Wolf Medical Instruments Corp., 1997) after a 78-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 26, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940464 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK940464 Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc. · 1994
- 1 generation backK963855 12 Ureteroscopes/Uretero-RenoscopesRichard Wolf Medical Instruments Corp. · 1997
- This deviceK990050 Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042Richard Wolf Medical Instruments Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940464 | Karl Storz Uretero-Renoscope/Ureterscope | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| −1 | K963855 | 12 Ureteroscopes/Uretero-Renoscopes | Richard Wolf Medical Instruments Corp. | 1997 | — |
| 0 (this device) | K990050 | Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042 | Richard Wolf Medical Instruments Corp. | 1999 | — |
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 |
|---|---|---|---|
| * | K963855 | 12 Ureteroscopes/Uretero-RenoscopesSummary page 1…teroscopes Classification name: Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 K963855 1 Uretero-renoscope 1 Richard Wolf 2 1.0 Description Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system… | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K963855.
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 compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and
kidney. Various diagnostic and therapeutic procedures can be performed by using
additional accessories.
+ transurethral extraction and lithotripsy of ureteroliths and kidney stones via
electrohydraulic, laser, pneumatic, or ultrasonic technology.
« tumor diagnostics and / or biopsy
+ removal of foreign bodies
The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible uretero-
renoscope and for evacuation of irrigation solution.
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/K990050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990050: Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990050
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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