510(k) · Cleared
ClearedPlasmatrode Saline Safe Tur Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 17, 2013 as substantially equivalent to K935874 (Cook Urological, Inc., 1994) and 3 other predicates after a 224-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 17, 2013
- Review
- 224 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K911904 (1991). 20 ancestors in all, the oldest K903323 (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 backK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
- This deviceK122716 Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd. · 2013
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 | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode… | Olympus Winter & Ibe GmbH | 2011 | 1 |
| 0 (this device) | K122716 | Plasmatrode Saline Safe Tur Electrode | Cook Ireland, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K935874 | Cook Coagulator ProbeSummary page 1…CER 878.4400, Product Code: GEl) Predicate Devices: COOKS Single-Use REF Electrode (COOK® Coagulator Probe, K935874), Gymus PK®'Plasma VTm Vaporization Electrode (K990628 - Gymos Endourology System) and the Olympus PK®… | 1994 |
| * | K990628 | Gyrus Endourology SystemSummary page 1…COOKS Single-Use REF Electrode (COOK® Coagulator Probe, K935874), Gymus PK®'Plasma VTm Vaporization Electrode (K990628 - Gymos Endourology System) and the Olympus PK® PlasmabuttonT ~lVapourization Electrode (K 100275 and… | 1999 |
| * | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Summary page 1…ization Electrode (K990628 - Gymos Endourology System) and the Olympus PK® PlasmabuttonT ~lVapourization Electrode (K 100275 and K102781 - HF-Rsection and Vaporization Electrode Series). Description of the The Plasmat… | 2010 |
| * | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Summary page 1…(K990628 - Gymos Endourology System) and the Olympus PK® PlasmabuttonT ~lVapourization Electrode (K 100275 and K102781 - HF-Rsection and Vaporization Electrode Series). Description of the The Plasmatrodeld Saline Safe TUR Electrode (also… | 2011 |
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 22 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 20 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
This device is used to vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia and for use with a compatible resectoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122716: Plasmatrode Saline Safe Tur Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122716
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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