510(k) · Cleared
ClearedGyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 28, 2002 as substantially equivalent to K000720 (Somnus Medical Technologies, Inc., 2000) after a 78-day review. Its family tree reaches back 1 generation to 2000. 77 later devices descend from it.
- Decided
- May 28, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000720 (2000). 77 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000720 Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable…Somnus Medical Technologies, Inc. · 2000
- This deviceK020778 Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Gyrus Ent LLC · 2002
- Descendant · cites it directly · 76 of its ownK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- Descendant · 2 generations on · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · 3 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 4 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 5 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC · 2002 · cites it directly76descendants
- K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · 2 generations on50descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 4 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000720 | Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector… | Somnus Medical Technologies, Inc. | 2000 | — |
| 0 (this device) | K020778 | Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420 | Gyrus Ent LLC | 2002 | — |
| +1 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| +2 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +3 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +4 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +5 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K000720 | Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector CableSummary page 2…tion, the current Model S2 Generator was cleared for use in conjunction with disposable soft tissue coagulation electrodes in K001438, and the RC-20 Cable was cleared in K000720. The Model 2420 Tissue Coagulating Electrode also is substantially the same as the Model 1420 Electrode that was cleared in K000… | 2000 |
What descends from it? (77)
See all 771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | 2002 | 76 |
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?
- Its one ancestor has no recall.
- Of its descendants, K021777 (Gyrus Ent LLC, 2002) has gone furthest, with 76 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 Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode is intended for use in the coagulation of tissues in the head and neck by qualified medical personnel trained in the use of electrosurgery. Indications for use for the Gyrus ENT Model 2420 Tissue Coagulating Electrode include the coagulation and reduction of enlarged tonsils for patients 13 years of age and older.
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/K020778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020778: Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020778
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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