510(k) · Cleared
Recalled · Class II · 2020Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 4, 2015 as substantially equivalent to K051627 (Valleylab, 2005) after a 137-day review. Its family tree reaches back 2 generations to 1981. It has been recalled 2 times.
- Decided
- Aug 4, 2015
- Review
- 137 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813071 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813071 | E2508 Disposable Handswitching Pencil | Valleylab, Inc. | 1981 | — |
| −1 | K051627 | Valleylab G3000 Electrosurgical Instrument | Valleylab | 2005 | — |
| 0 (this device) | K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse… | Covidien | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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? (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 |
|---|---|---|---|
| * | K051627 | Valleylab G3000 Electrosurgical InstrumentSummary page 4…Predicate Devices These devices are legally marketed devices, manufactured by Covidien llc. The Force Triverse devices were originally cleared for marketing under 510(k) K051627. These instruments serve as their own predicate devices. Device Description The Force TriVerse Electrosurgical Devices are radiat… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2020 | Class II | Z-1446-2020 | Process control | Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. |
| Feb 15, 2019 | Class II | Z-1020-2019 | Equipment maintenance | Potential for the sterile packaging to be compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 23.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K051627.
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?
The Force TriVerse Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic), and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150735: Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150735
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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