510(k) · Cleared
ClearedGyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes)
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 Aug 26, 2002 as substantially equivalent to K020067 (Gyrus Ent LLC, 2002) and 11 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1994. 76 later devices descend from it.
- Decided
- Aug 26, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 7 generations to K936109 (1994). 63 ancestors in all, the oldest K800617 (1980). 76 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 3 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 2 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 1 generation backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- This deviceK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- Descendant · cites it directly · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · 2 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 4 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 4 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · cites it directly50descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −3 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −1 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| 0 (this device) | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| +1 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +2 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +4 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +4 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
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 |
|---|---|---|
| 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? (12)
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 |
|---|---|---|---|
| * | K020067 | Gyrus Ent Somnoplasty GeneratorSummary page 1…Accessories (per 2 1 CFR 878.4400) Predicate Devices: - Gyrus ENT Somnoplasty Generator (K020067) - Gyrus Medical Inc PlasmaKinetic Generator… | 2002 |
| * | K003060 | Plasmakinetic GeneratorSummary page 1…- Gyrus Medical Inc PlasmaKinetic Generator (K003060) - Arthrocare Sinus Electrosurgery Generator (K973478)… | 2000 |
| * | K973478 | Arthrocare Sinus Electrosurgery SystemSummary page 1…(K003060) - Arthrocare Sinus Electrosurgery Generator (K973478) - Arthrocare ENTec Plasma Wands (KO14290)… | 1998 |
| * | K014290 | Entec Plasma Wands | 2002 |
| * | K011279 | Entec Evac Plasma Wand | 2001 |
| * | K002021 | Hemostatix Thermal Scalpel System - #12 Blade | 2000 |
| * | K982717 | Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200Summary page 1…- Gyrus ENT TCRF Somnoplasty Electrodes (K982717), (K97361 8), (K971450), & (K020778) Description: The Gyrus ENT G I1 RF Workstation is a combination of two previously… | 1998 |
| * | K973618 | Somnoplasty SystemSummary page 1…- Gyrus ENT TCRF Somnoplasty Electrodes (K982717), (K97361 8), (K971450), & (K020778) Description: The Gyrus ENT G I1 RF Workstation is a combination of two previously cleared radi… | 1997 |
| * | K971450 | Somnoplasty SystemSummary page 1…- Gyrus ENT TCRF Somnoplasty Electrodes (K982717), (K97361 8), (K971450), & (K020778) Description: The Gyrus ENT G I1 RF Workstation is a combination of two previously cleared radio-frequency… | 1997 |
| * | K020778 | Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Summary page 1…- Gyrus ENT TCRF Somnoplasty Electrodes (K982717), (K97361 8), (K971450), & (K020778) Description: The Gyrus ENT G I1 RF Workstation is a combination of two previously cleared radio-frequency generato… | 2002 |
| * | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma WandSummary page 2…O2 1777, the PlasmaKinetic Generator section of the GI1 RF Workstation is substantially equivalent to the ArthroCare ENTec Plasma Wand cleared under 510(k) Nos. KO14290, K013463, KO1 1279, K000228, and K973478. Testing was presented in our July 19,2002, supplement to KO21777 that demonstrated the The Plasm… | 2001 |
| * | K000228 | Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma WandSummary page 2…Kinetic Generator section of the GI1 RF Workstation is substantially equivalent to the ArthroCare ENTec Plasma Wand cleared under 510(k) Nos. KO14290, K013463, KO1 1279, K000228, and K973478. Testing was presented in our July 19,2002, supplement to KO21777 that demonstrated the The PlasmaKinetic Generator… | 2000 |
What descends from it? (76)
See all 763 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)
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 8 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 63 ancestors have a recall of any class.
- Of its descendants, K034004 (Gyrus Ent LLC, 2004) has gone furthest, with 50 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 PlasmaKinetic Generator section of the GI1 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…
Read the full statement (207 words)
The PlasmaKinetic Generator section of the GI1 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
Submucosal Palatal Shrinkage
Tonsillectomy
Traditional Uvulopalatoplasty (RAUP)
Tumors
Tissue in the UvuldSoft Palate for the Treatment of Snoring
The Gyrus ENT Sornnoplasty TCRF Generator section of the GI1 R F Workstation with the Temperature Controlled Radio-frequency (SornnoplastyB) 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/K021777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories 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/K021777
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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