# K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Ltd.
- Decided: Sep 10, 2004 after 120 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 64 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Ent LLC (2002) Summary page 1.

## Most influential descendants
- K050550: Gyrus General Purpose Electrosurgical Generator (2005), 14 descendants of its own
- K050460: Gyrus Plasmacision and Plasmablend Electrodes (2005), 6 descendants of its own
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), 3 descendants of its own
- K100896: Gyrus Acmi Halo PKS Cutting Forceps (2010), 3 descendants of its own
- K081766: PKS Omni Instrument (2008), 3 descendants of its own

## Recalls of this device
- Aug 6, 2010 · Not classified · Z-2651-2010: Lack of sterility assurance due to compromised package seals.
- Oct 1, 2008 · Not classified · Z-0273-2009: Sterility may be compromised

## Indications for use
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.

Source page: https://510kreport.com/device/K041285
Methodology: https://510kreport.com/methodology