510(k) · Cleared
ClearedVigeon Laparoscopic Universal Smoke Evacuator (VG003)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vigeon Technology Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 9, 2025 as substantially equivalent to K160128 (Ethicon Endo-Surgery, LLC, 2016) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 9, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K936304 (1994). 7 ancestors in all, the oldest K912492 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- 2 generations backK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- 1 generation backK213317 ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd. · 2022
- This deviceK250400 Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936304 | Electrosurgical Pencil | E & M Engineering, Inc. | 1994 | 3 |
| −2 | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| −1 | K213317 | ShinEvac Smoke Evacuation Pencil | Shining World Health Care Co., Ltd. | 2022 | — |
| 0 (this device) | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K160128 | Endopath Electrosurgery Probe Plus IISummary page 5…on 21 CFR 878.4400 Product Code GEI Device Class II 3 Predicate Device 510(k) number: K160128 Proprietary name: Endopath® Electrosurgery Probe Plus II Product Code GEI 510(k)… | 2016 |
| * | K213317 | ShinEvac Smoke Evacuation PencilSummary page 5…K160128 Proprietary name: Endopath® Electrosurgery Probe Plus II Product Code GEI 510(k) number: K213317 Proprietary name: ShinEvac® Smoke Evacuation Pencil Product Code GEI 4 Device Descr… | 2022 |
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 31 years and passes through 4 companies; a new generation was cleared every 10.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K160128.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 product is indicated for use in minimally invasive procedures for removing smoke generated by electrocautery and small amount of fluids when used in conjunction with an effective suction equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250400: Vigeon Laparoscopic Universal Smoke Evacuator (VG003).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250400
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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