510(k) · Cleared
ClearedFlexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253
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 Jun 11, 1999 as substantially equivalent to K980401 (Richard Wolf Medical Instruments Corp., 1998) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 11, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940464 (1994). 4 ancestors in all. 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 deviceK991178 Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac…Richard 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) | K991178 | Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece… | Richard Wolf Medical Instruments Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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 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? (2)
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 |
|---|---|---|---|
| * | K980401 | Flexible Fiberscopes and AccessoriesSummary page 5…Flexible Fiberscope 7331.001 Common name: lassification Name: Flexible Fiberscopes lexible Endoscopes 510(k) Number Trade or proprietary or model name Manufacturer 1 K980401 1 Flexible Fiberscopes 1 Richard Wolf 2 K963855 2 Compact Operating Ureteroscopes & Uretero- 2 Richard Wolf Renoscopes Devices (… | 1998 |
| * | K963855 | 12 Ureteroscopes/Uretero-RenoscopesSummary page 5…fication Name: Flexible Fiberscopes lexible Endoscopes 510(k) Number Trade or proprietary or model name Manufacturer 1 K980401 1 Flexible Fiberscopes 1 Richard Wolf 2 K963855 2 Compact Operating Ureteroscopes & Uretero- 2 Richard Wolf Renoscopes Devices (URS) : 3 4 4 5 5 5 6 6 6 1.0 Description The fle… | 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 4 ancestors has a recall.
- 2 other devices also cite its predicate K980401.
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 flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses. For examination, diagnosis, and / or therapy in connection with endoscopic accessories and auxiliary instruments, in particular, for intracorporal flexible lithotripsy probes, e.g., pneumatic or electrohydraulic, used through the working channel of the instrument. The instruments are used in the medical disciplines of urology…
Read the full statement (107 words)
The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses.
For examination, diagnosis, and / or therapy in connection with endoscopic accessories and auxiliary instruments, in particular, for intracorporal flexible lithotripsy probes, e.g., pneumatic or electrohydraulic, used through the working channel of the instrument.
The instruments are used in the medical disciplines of urology, surgery, gynecology, and ENT by adequately trained and qualified medical personnel. Applications to the heart, the central nervous system, and the circulatory systems are excluded.
Important! Product dimensions must correspond to the anatomic requirements, i.e., use the flexible fiberscope appropriate to the medical discipline.
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/K991178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991178: Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991178
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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