510(k) · Cleared
ClearedStryker Flexible Cystonephroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Mar 15, 2005 as substantially equivalent to K904797 (Surgitek, 1991) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.
- Decided
- Mar 15, 2005
- Review
- 132 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904797 (1991). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904797 Surgitek Graduated Cystoscope (Model GC-16)Surgitek · 1991
- This deviceK043022 Stryker Flexible CystonephroscopeStryker Endoscopy · 2005
- Descendant · cites it directly · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 3 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · 3 generations on · 6 of its ownK172844 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · cites it directly10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 2 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 3 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
- K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904797 | Surgitek Graduated Cystoscope (Model GC-16) | Surgitek | 1991 | — |
| 0 (this device) | K043022 | Stryker Flexible Cystonephroscope | Stryker Endoscopy | 2005 | — |
| +1 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +3 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +3 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FAJ? 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 |
|---|---|---|---|
| * | K904797 | Surgitek Graduated Cystoscope (Model GC-16)Summary page 1…substantially equivalent in terms of safety Storz The Stryker Flexible CystoNephroscope is CystoNephroscope (K904797) and the Karl effectiveness to the currently marketed ACMI ACN-2 11001 DO Nephro-Fiberscope (K970427).… | 1991 |
| * | K970427 | Ksea Uretero-Reno-Fiberscope and Nephro-FiberscopeSummary page 1…er Flexible CystoNephroscope is CystoNephroscope (K904797) and the Karl effectiveness to the currently marketed ACMI ACN-2 11001 DO Nephro-Fiberscope (K970427). of the currently marketed Stryker The St… | 1997 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and… | 2014 | 10 |
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?
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.
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 Stryker Flexible CystoNephroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices or through percutaneous access, and is intended for but not limited to, examining the urinary tract and the interior of the kidney, and, using additional accessories, performing various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043022: Stryker Flexible Cystonephroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043022
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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