510(k) · Cleared
ClearedCystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canada Endoscope Corporation · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Aug 30, 2010 as substantially equivalent to K031141 (Asap Endoscopic Products GmbH, 2003) after a 270-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 30, 2010
- Review
- 270 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963426 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK963426 Karl Storz Contact Micro-LaryngoscopesKARL STORZ Endoscopy-America, Inc. · 1996
- 1 generation backK031141 Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap…Asap Endoscopic Products GmbH · 2003
- This deviceK093725 Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C…Canada Endoscope Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963426 | Karl Storz Contact Micro-Laryngoscopes | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| −1 | K031141 | Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope | Asap Endoscopic Products GmbH | 2003 | — |
| 0 (this device) | K093725 | Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C… | Canada Endoscope Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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? (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 |
|---|---|---|---|
| * | K031141 | Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap OesophagoscopeSummary page 1…e Identification 21 CFR 876.1500 Endoscope and Accessories Product Code FAJ Device Class 11 3. Legally Marketed Equivalent Device Asap Cystoscope (K031 141) 4. Intended Use and Device Description Like the predicate devices, the Canada Endoscope is used to visualize the body cavitie… | 2003 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K031141.
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. 2010, 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?
Like the predicated devices, the Canada Endloscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093725: Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093725
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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