510(k) · Cleared
ClearedResection Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · JOS Electrode, Electrosurgical
Cleared on Sep 6, 2016 as substantially equivalent to K152092 (Olympus Winter & Ibe GmbH, 2015) after an 89-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 6, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- JOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K911904 (1991). 23 ancestors in all, the oldest K897003 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 5 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 4 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 3 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 2 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 1 generation backK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
- This deviceK161600 Resection ElectrodesOlympus Winter & Ibe GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −5 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −4 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −3 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −2 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −1 | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | 1 |
| 0 (this device) | K161600 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2003 | 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 JOS? 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? (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 |
|---|---|---|---|
| * | K152092 | Resection ElectrodesSummary page 4…WA47551S, WA47555S, WA47560S, WA47566S 3. Predicate Devices The subject devices have been previously cleared for urological indications under K152092 (product codes FAS / FJL). 1… | 2015 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K152092.
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.
The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in saline irrigation fluid.
Specific indications:
- transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
- lysis of intrauterine septa
- endometrial ablation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161600: Resection Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161600
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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