# K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Aug 26, 2002 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K936109 (1994). 63 ancestors in all.
76 later devices descend from it; 3 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020067: Gyrus Ent Somnoplasty Generator, Gyrus Ent LLC (2002) Summary page 1.
- K003060: Plasmakinetic Generator, Everest Medical Corp. (2000) Summary page 1.
- K973478: Arthrocare Sinus Electrosurgery System, Arthrocare Corp. (1998) Summary page 1.
- K014290: Entec Plasma Wands, Arthrocare Corp. (2002)
- K011279: Entec Evac Plasma Wand, Arthrocare Corp. (2001)
- K002021: Hemostatix Thermal Scalpel System - #12 Blade, Gyrus Ent LLC (2000)
- K982717: Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200, Somnus Medical Technologies, Inc. (1998) Summary page 1.
- K973618: Somnoplasty System, Somnus Medical Technologies, Inc. (1997) Summary page 1.
- K971450: Somnoplasty System, Somnus Medical Technologies, Inc. (1997) Summary page 1.
- K020778: Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420, Gyrus Ent LLC (2002) Summary page 1.
- K013463: Arthrocare Arthro Wands, Enetec Evac Plasma Wand, Arthrocare Corp. (2001) Summary page 2.
- K000228: Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand, Arthrocare Corp. (2000) Summary page 2.

## Most influential descendants
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K021777
Methodology: https://510kreport.com/methodology