510(k) · Cleared
Recalled · 2010Flexible and Rigid Ureterotome System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · EZO Urethrotome
Cleared on Jan 7, 1992 after a 432-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 7, 1992
- Review
- 432 days
- Class
- Class II
- Product code
- EZO
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK904939 Flexible and Rigid Ureterotome SystemOlympus Corp. · 1992
- Descendant · cites it directly · 2 of its ownK992141 Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999
- Descendant · 2 generations on · 1 of its ownK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK950719 Oes UrologyOlympus America, Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999 · cites it directly2descendants
- K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005 · 2 generations on1descendant
- K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006 · 3 generations on0descendants
- K950719Oes UrologyOlympus America, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904939 | Flexible and Rigid Ureterotome System | Olympus Corp. | 1992 | — |
| +1 | K992141 | Olympus Working Element for Probes | Olympus Winter & Ibe GmbH | 1999 | — |
| +2 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
| +3 | K053322 | Modification to: Roei Working Element and Roei Cutting Loops | Roei Medical Technologies, Ltd. | 2006 | — |
| +1 | K950719 | Oes Urology | Olympus America, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2010 | Not classified | Z-3102-2011 | Packaging process control | The device sterile package seal shows evidence of being breached or was breached |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992141 (Olympus Winter & Ibe GmbH, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EZO devicesEZO Urethrotome: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZO
FDA has decided no EZO device since 2007.
Median 510(k) review, days · EZO
Too few EZO 510(k)s in any year since 2007 to give a median.
Recalls per year · EZO
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZO
1in 2024
MAUDE reports naming product code EZO, 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 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904939: Flexible and Rigid Ureterotome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904939
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026