510(k) · Cleared
ClearedErbe Vio Esu, Model Vio 300 D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 16, 2006 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) after a 20-day review. Its family tree reaches back 2 generations to 1994. 115 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933002 (1994). 115 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 1 generation backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- This deviceK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- Descendant · cites it directly · 55 of its ownK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- Descendant · 2 generations on · 39 of its ownK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- Descendant · cites it directly · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · cites it directly · 16 of its ownK071728 Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007
- Descendant · 2 generations on · 15 of its ownK110639 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011 · Recalled
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008 · cites it directly55descendants
- K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation · 2014 · 2 generations on39descendants
- K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · cites it directly16descendants
- K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007 · cites it directly16descendants
- K110639Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −1 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| 0 (this device) | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| +1 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| +2 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| +1 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +1 | K071728 | Modification to: Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2007 | — |
| +2 | K110639 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 13 | 0 |
| 2023 | 12 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 1…8.4400) Product Code: GEl Legally Marketed ERBE VIO ESU (Model VIO 300 D)with Accessories Predicate Device: 510(k) Number: K023886 Device Description: The ERBE VIQ ESU with Accessories is an electrosurgical system that uses high frequency (HF) electrical cur… | 2002 |
What descends from it? (115)
See all 1159 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083452 | Erbe Model Vio 300 D with Accessories | 2008 | 55 |
| K110268 | Forcetriad Electrosurgical Generator | 2011 | 16 |
| K071728 | Modification to: Enseal PTC Tissue Sealing Device | 2007 | 16 |
| K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | 2007 | 14 |
| K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal… | 2011 | 12 |
| K171717 | Autocon Iii 400 | 2017 | 2 |
| K081678 | Conmed Beamer System C600 | 2008 | 1 |
| K080715 | Erbe Vio Esu, Model Vio 200 S | 2008 | 1 |
| K061544 | Stellartech 100 Coagulation System | 2006 | 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 12 years and passes through 1 company; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083452 (Erbe USA, Inc., 2008) has gone furthest, with 55 descendants of its own.
- 8 other devices also cite its predicate K023886.
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 ERBE VIO ESU with Accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060484: Erbe Vio Esu, Model Vio 300 D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060484
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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