510(k) · Cleared
ClearedOlympus Working Element for Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · FDC Resectoscope, Working Element
Cleared on Sep 29, 1999 as substantially equivalent to K790071 (Olympus Corp., 1979) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it.
- Decided
- Sep 29, 1999
- Review
- 97 days
- Class
- Class II
- Product code
- FDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K790071 (1979). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK790071 Endoscope and AccessoriesOlympus Corp. · 1979 · Recalled
- This deviceK992141 Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999
- Descendant · cites it directly · 1 of its ownK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| 0 (this device) | K992141 | Olympus Working Element for Probes | Olympus Winter & Ibe GmbH | 1999 | — |
| +1 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
| +2 | K053322 | Modification to: Roei Working Element and Roei Cutting Loops | Roei Medical Technologies, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 FDC? 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? (4)
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 |
|---|---|---|---|
| * | K790071 | Endoscope and AccessoriesSummary page 1…ment with open handle and probe guide unknown channel Type 8654.281 Richard Wolf |Injection cannula flexible, 4.5 Fr Type 8654.951 unknown Olympus Working element 03523 K790071 Olympus Working element, V-spring type A3573 K904939 Olympus Working element, V-spring type A2496 K904939 Olympus Knife, semi cir… | 1979 |
| * | K904939 | Flexible and Rigid Ureterotome SystemSummary page 1…Type 8654.281 Richard Wolf |Injection cannula flexible, 4.5 Fr Type 8654.951 unknown Olympus Working element 03523 K790071 Olympus Working element, V-spring type A3573 K904939 Olympus Working element, V-spring type A2496 K904939 Olympus Knife, semi circular, 3 Fr. channel, for A2496 K904939 Olympus Stric… | 1992 |
| * | — | Working element with open handle and probe guide channel Type 8654.281 Named without a submission number | |
| * | — | Injection cannula flexible, 4.5 Fr Type 8654.951 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050910 | Roei Working Element and Roel Cutting Loops | 2005 | 1 |
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 FDC devicesFDC Resectoscope, Working Element: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDC
FDA has decided no FDC device since 2007.
Median 510(k) review, days · FDC
Too few FDC 510(k)s in any year since 2007 to give a median.
Recalls per year · FDC
No recall names FDC since 2007.
Adverse event reports per year · FDC
19in 2025
MAUDE reports naming product code FDC, 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 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.
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/K992141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992141: Olympus Working Element for Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992141
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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