510(k) · Cleared
Recalled · 2010Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 10, 2004 as substantially equivalent to K021777 (Gyrus Ent LLC, 2002) after a 120-day review. Its family tree reaches back 8 generations to 1994. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 10, 2004
- Review
- 120 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K936109 (1994). 64 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- This deviceK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004
- Descendant · cites it directly · 14 of its ownK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK050460 Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK100896 Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005 · cites it directly14descendants
- K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005 · cites it directly6descendants
- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · 2 generations on3descendants
- K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · 2 generations on3descendants
- K081766PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −1 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| 0 (this device) | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and… | Gyrus Medical, Ltd. | 2004 | — |
| +1 | K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus Medical, Inc. | 2005 | — |
| +1 | K050460 | Gyrus Plasmacision and Plasmablend Electrodes | Gyrus Medical, Inc. | 2005 | — |
| +2 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +2 | K100896 | Gyrus Acmi Halo PKS Cutting Forceps | Gyrus Acmi, Inc. | 2010 | 1 |
| +2 | K081766 | PKS Omni Instrument | Gyrus-Acmi L.P. | 2008 | 1 |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Summary page 1…Accessories (per 21 CFR 878.4400) Brand Name: Not yet assigned Predicate Devices: K021777 (G2 Radio-frequency Workstation & Accessories) Gyrus Medical, Cardiff… | 2002 |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2010 | Not classified | Z-2651-2010 | Packaging | Lack of sterility assurance due to compromised package seals. |
| Oct 1, 2008 | Not classified | Z-0273-2009 | Process control | Sterility may be compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 64 ancestors have a recall of any class.
- Of its descendants, K050550 (Gyrus Medical, Inc., 2005) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K021777.
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 Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: · Adenoidectomy · Cysts · Head, Neck, Oral, and Sinus Surgery · Mastoidectomy · Myringotomy with effective Hemorrhage Control · Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates · Nasopharyngeal / Laryngeal indications…
Read the full statement (228 words)
The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
· Adenoidectomy
· Cysts
· Head, Neck, Oral, and Sinus Surgery
· Mastoidectomy
· Myringotomy with effective Hemorrhage Control
· Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
· Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
· Neck Mass
· Papilloma Keloids
· Sububifis aT'alata Shrinkage
· Tonsillectomy
· Traditional Uvulopalatoplasty (RAUP)
· Tumors
· Tissue in the Uvula/Soft Palate for the Treatment of Snoring
· Uvulopalatopharyngoplasty (UPPP)
· Parotidectomy
· Radical Neck Disection
The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:
The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following Head and Neck surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041285
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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