510(k) · Cleared
ClearedUro-N Cystoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uroviu Corporation · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Jul 2, 2019 as substantially equivalent to K171602 (Cook Incorporated, 2017) and 1 other predicate after a 263-day review. Its family tree reaches back 6 generations to 1982. 1 of the 23 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 2, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K820973 (1982). 22 ancestors in all, the oldest K812057 (1981). No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 5 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 4 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 3 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 2 generations backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- 1 generation backK171602 Williams Cystoscopic Injection NeedleCook Incorporated · 2017 · Recalled
- This deviceK182876 Uro-N CystoscopeUroviu Corporation · 2019
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope3 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −5 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −4 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −3 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −2 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| −1 | K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017 | 1 |
| 0 (this device) | K182876 | Uro-N Cystoscope | Uroviu Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1991 | 1 | 1 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2018 | 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.
1 device in this family has a Class I recall. 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 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 |
|---|---|---|---|
| * | K171602 | Williams Cystoscopic Injection NeedleSummary page 4…Trade Name Williams Cystoscopic Injection Needle Common Name Williams injection needle Premarket Notification K171602 Regulation Number and 21 CFR§876.1500, Endoscope and Accessories Classification Name Product Code… | 2017 |
| * | K171500 | Uro-V CystoscopeSummary page 4…Predicate Device Trade Name Uro-V Cystoscope Common Name Uro-V cystoscope Premarket Notification K171500 Regulation Number and 21 CFR§876.1500, Endoscope and Accessories Classification Name K182876… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- 7 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
The Uro-N Cystoscope is intended for directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182876: Uro-N Cystoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182876
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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