510(k) · Cleared
ClearedE0520-Trigger Switch and Cord/E0521-Trigger Switch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 28, 1997 as substantially equivalent to K904560 (Valleylab, Inc., 1990) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904560 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904560 Valleylab Laparoscopic Handswitch/ElectrodesValleylab, Inc. · 1990
- This deviceK970140 E0520-Trigger Switch and Cord/E0521-Trigger SwitchValleylab, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK200455 Trigger Switch and CordNew Deantronics Taiwan, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK060117 Bovie Button Remote Hand SwitchAaron Medical Industries · 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 | K904560 | Valleylab Laparoscopic Handswitch/Electrodes | Valleylab, Inc. | 1990 | — |
| 0 (this device) | K970140 | E0520-Trigger Switch and Cord/E0521-Trigger Switch | Valleylab, Inc. | 1997 | — |
| +1 | K200455 | Trigger Switch and Cord | New Deantronics Taiwan, Ltd. | 2020 | — |
| +1 | K060117 | Bovie Button Remote Hand Switch | Aaron Medical Industries | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K904560 | Valleylab Laparoscopic Handswitch/ElectrodesSummary page 1…Switch and Cord accessories are substantially equivalent in function and intended use to the following legally marketed devices: E2750, Laparoscopic Pencil Grip Handset (K904560); E2751, Laparoscopic Pistol Grip Handset (K925647); and E0510 Laparoscopic Cord (Preamendments Device). The Trigger Switch and… | 1990 |
| * | K925647 | Valleylab #E2751 & E2780R Laparoscopic HandpieceSummary page 1…alent in function and intended use to the following legally marketed devices: E2750, Laparoscopic Pencil Grip Handset (K904560); E2751, Laparoscopic Pistol Grip Handset (K925647); and E0510 Laparoscopic Cord (Preamendments Device). The Trigger Switch and Cord are substantially equivalent to the above devi… | 1993 |
| * | — | E0510 Laparoscopic Cord Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Trigger Switch and Cord accessories are intended for use in
monopolar laparoscopic and thoracoscopic electrosurgical procedures
where handswitching of laparoscopic or thoracoscopic instruments, such as
scissors and graspers, is desired.
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/K970140 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970140: E0520-Trigger Switch and Cord/E0521-Trigger Switch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970140
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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