510(k) · Cleared
ClearedForce Argon II Argon Enhanced Electrosurgical System
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 11, 1997 after a 112-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 11, 1997
- Review
- 112 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK964636 Force Argon II Argon Enhanced Electrosurgical SystemValleylab, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK191064 Argon HandsetNew Deantronics Taiwan, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK183126 Electrosurgical accessoryNew Deantronics Taiwan, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK122092 Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012
- Descendant · cites it directly · 0 of its ownK113500 Canady Vieira Hybrid Plasma ScalpelUs Medical Innovations, LLC · 2011
- Descendant · cites it directly · 0 of its ownK062082 Conmed Abc Dissecting Blade Electrode, Model 139330; Blunt Needle…Conmed Corporation · 2007
Most influential descendants
Showing 5 of 5 · See all- K191064Argon HandsetNew Deantronics Taiwan, Ltd. · 2019 · cites it directly0descendants
- K183126Electrosurgical accessoryNew Deantronics Taiwan, Ltd. · 2019 · cites it directly0descendants
- K122092Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012 · cites it directly0descendants
- K113500Canady Vieira Hybrid Plasma ScalpelUs Medical Innovations, LLC · 2011 · cites it directly0descendants
- K062082Conmed Abc Dissecting Blade Electrode, Model 139330; Blunt Needle Electrode, Model 139331Conmed Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964636 | Force Argon II Argon Enhanced Electrosurgical System | Valleylab, Inc. | 1997 | — |
| +1 | K191064 | Argon Handset | New Deantronics Taiwan, Ltd. | 2019 | — |
| +1 | K183126 | Electrosurgical accessory | New Deantronics Taiwan, Ltd. | 2019 | — |
| +1 | K122092 | Medrange Electrosurgical Expansion System | Medrange Corporation | 2012 | — |
| +1 | K113500 | Canady Vieira Hybrid Plasma Scalpel | Us Medical Innovations, LLC | 2011 | — |
| +1 | K062082 | Conmed Abc Dissecting Blade Electrode, Model 139330; Blunt Needle Electrode… | Conmed Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | — | Valleylab Force GSU® Argon Enhanced Electrosurgical System Named without a submission number | |
| * | — | Valleylab Force GSU® System with Laparoscopic option Named without a submission number | |
| * | — | Valleylab Force GSU® - SLPM System Named without a submission number |
What descends from it? (5)
5 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?
- Of its descendants, K191064 (New Deantronics Taiwan, Ltd., 2019) has gone furthest, with 0 descendants of its own.
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 Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.
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/K964636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964636: Force Argon II Argon Enhanced Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964636
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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