510(k) · Cleared
ClearedG3 Generator and Accessories-Dissector Plasma Knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 13, 2009 as substantially equivalent to K041285 (Gyrus Medical, Ltd., 2004) after a 505-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Aug 13, 2009
- Review
- 505 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K936109 (1994). 65 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 1 generation backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- This deviceK080844 G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK131205 Arthrocare Head and Neck Coblation WandArthroCare Corporation · 2013
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 1 generation backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- This deviceK080844 G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −3 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −2 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| −1 | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and… | Gyrus Medical, Ltd. | 2004 | 2 |
| 0 (this device) | K080844 | G3 Generator and Accessories-Dissector Plasma Knife | Gyrus Acmi, Inc. | 2009 | — |
| +1 | K131205 | Arthrocare Head and Neck Coblation Wand | ArthroCare Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Summary page 1…coagulation devices and accessories Predicate Devices Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife K041285 Intended Uses The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131205 | Arthrocare Head and Neck Coblation Wand | 2013 | 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 15 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 65 ancestors have a recall of any class.
- Of its descendants, K131205 (ArthroCare Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041285.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: · Adenoidectomy Papilloma Keloids · Cysts Submucosal Palatal Shrinkage · Head, Neck' Oral, and Sinus Surgery Tonsillectomy · Mastoidectomy Traditional Uvulopalatoplasty (RAUP) · Myringotomy with effective Hemorrhage Tumors…
Read the full statement (157 words)
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for
ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in
otorhinolaryngology (Head and Neck) surgery including:
· Adenoidectomy Papilloma Keloids
· Cysts Submucosal Palatal Shrinkage
· Head, Neck' Oral, and Sinus Surgery Tonsillectomy
· Mastoidectomy Traditional Uvulopalatoplasty (RAUP)
· Myringotomy with effective Hemorrhage Tumors
Control Tissue in the Uvula/Soft Palate for the
· Nasal Airway Obstruction by Reduction of Treatment of Snoring
Hypertrophic Nasal Turbinates Uvulopalatopharyngoplasty (UPPP)
· Nasopharyngeal / Laryngeal indications Parotidectomy
including Tracheal Procedures, Laryngeal
Polypectomy, and Laryngeal Lesion Debulking Neck Mass
· Neck Dissection (Radical and Modified Neck Dissection)
The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft
tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection,
(Radical and Modified Neck Dissection), Tonsillectomy, Parotidectomy and UPPP when used
with the bipolar generator section of the G3 Workstation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080844: G3 Generator and Accessories-Dissector Plasma Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080844
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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