510(k) · Cleared
ClearedGyrus General Purpose Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 9, 2005 as substantially equivalent to K041285 (Gyrus Medical, Ltd., 2004) and 2 other predicates after a 251-day review. Its family tree reaches back 9 generations to 1994. 14 later devices descend from it.
- Decided
- Nov 9, 2005
- Review
- 251 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K936109 (1994). 69 ancestors in all, the oldest K800617 (1980). 14 later devices descend from it, 5 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 deviceK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK100896 Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · Recalled
- Descendant · cites it directly · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK142759 PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015
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 deviceK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · cites it directly3descendants
- K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · cites it directly3descendants
- K081766PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · cites it directly3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 2 generations on2descendants
- K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015 · 2 generations on2descendants
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) | K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus Medical, Inc. | 2005 | — |
| +1 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +1 | K100896 | Gyrus Acmi Halo PKS Cutting Forceps | Gyrus Acmi, Inc. | 2010 | 1 |
| +1 | K081766 | PKS Omni Instrument | Gyrus-Acmi L.P. | 2008 | 1 |
| +2 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +2 | K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015 | — |
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 | 13 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (3)
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…Accessories (per 21 CFR 878.4400) Brand Name: Not yet assigned Predicate Devices: K041285 (Gyrus ENT G3 System) K031085 (Gyrus Superpulse® System)… | 2004 |
| * | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Summary page 1…00) Brand Name: Not yet assigned Predicate Devices: K041285 (Gyrus ENT G3 System) K031085 (Gyrus Superpulse® System) K002906 (Harmonic Scalpel®) Description: The Gyrus General Pur… | 2003 |
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 1…vices: K041285 (Gyrus ENT G3 System) K031085 (Gyrus Superpulse® System) K002906 (Harmonic Scalpel®) Description: The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has contr… | 2000 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | 2011 | 3 |
| K100896 | Gyrus Acmi Halo PKS Cutting Forceps | 2010 | 3 |
| K081766 | PKS Omni Instrument | 2008 | 3 |
| K081954 | Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable | 2008 | 0 |
| K071759 | LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand… | 2008 | 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 11 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 69 ancestors have a recall of any class.
- Of its descendants, K111059 (Gyrus Acmi, Inc., 2011) has gone furthest, with 3 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.
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 generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050550: Gyrus General Purpose Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050550
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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