510(k) · Cleared
ClearedBovie Icon GI Electrosurgical Generator, Model GI 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bovie Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 6, 2006 as substantially equivalent to K022856 (Aaron Medical Industries, 2003) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944602 (1995). 4 ancestors in all, the oldest K933157 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944602 Valleylab Force FXValleylab, Inc. · 1995
- 1 generation backK022856 Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries · 2003
- This deviceK061884 Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical · 2006
- Descendant · cites it directly · 1 of its ownK082109 Bovie Icon General Purpose RF GeneratorBovie Medical · 2008
- Descendant · 2 generations on · 0 of its ownK092383 Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation · 2010
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 |
|---|---|---|---|---|---|
| −2 | K944602 | Valleylab Force FX | Valleylab, Inc. | 1995 | — |
| −1 | K022856 | Bovie Ids-300 High Frequency Electrosurgical Generator | Aaron Medical Industries | 2003 | — |
| 0 (this device) | K061884 | Bovie Icon GI Electrosurgical Generator, Model GI 120 | Bovie Medical | 2006 | — |
| +1 | K082109 | Bovie Icon General Purpose RF Generator | Bovie Medical | 2008 | — |
| +2 | K092383 | Bovie Icon VS General Purpose RF Generator, Model: VS300 | Bovie Medical Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K022856 | Bovie Ids-300 High Frequency Electrosurgical GeneratorSummary page 1…IDS-300 Hfigh Frequency Electrosurgical Generator K022856 ERBE USA, Inc. Erbotom ICC 200 K933 157… | 2003 |
| * | K933157 | Erbotom Icc 200Summary page 1…Electrosurgical Generator K022856 ERBE USA, Inc. Erbotom ICC 200 K933 157 5-2 7100 30th Avenue North * St. Petersburg,… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082109 | Bovie Icon General Purpose RF Generator | 2008 | 1 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082109 (Bovie Medical, 2008) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K022856.
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 Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061884: Bovie Icon GI Electrosurgical Generator, Model GI 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061884
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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