510(k) · Cleared
ClearedNICO TRIOwand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nico Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 23, 2015 as substantially equivalent to K960455 (Kirwan Surgical Products, Inc., 1996) and 1 other predicate after an 8-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Apr 23, 2015
- Review
- 8 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923332 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 2 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 1 generation backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- This deviceK150993 NICO TRIOwandNico Corporation · 2015
- Descendant · cites it directly · 0 of its ownK162075 NICO TRIOwandNico Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K162075NICO TRIOwandNico Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −2 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −1 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| 0 (this device) | K150993 | NICO TRIOwand | Nico Corporation | 2015 | — |
| +1 | K162075 | NICO TRIOwand | Nico Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K960455 | Bipolar Suction CoagulatorSummary page 4…accessories Classification 21 CFR §878.4400 (Class II) Product Code GEI Kirwan Bipolar Suction Coagulator; K960455 Predicate Devices SilverGlide Non-Stick Bipolar Forceps; K992931 Device Description The NICO TRIOwand is a surgeon… | 1996 |
| * | K992931 | Non-Stick Bipolar ForcepsSummary page 4…Product Code GEI Kirwan Bipolar Suction Coagulator; K960455 Predicate Devices SilverGlide Non-Stick Bipolar Forceps; K992931 Device Description The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162075 | NICO TRIOwand | 2016 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K162075 (Nico Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K960455.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and
low energy output for the coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150993: NICO TRIOwand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150993
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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