# K080844: G3 Generator and Accessories-Dissector Plasma Knife

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Aug 13, 2009 after 505 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: 9 generations back to K936109 (1994). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Medical, Ltd. (2004) Summary page 1.

## Most influential descendants
- K131205: Arthrocare Head and Neck Coblation Wand (2013), 0 descendants of its own

## Indications for use
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: · Adenoidectomy Papilloma Keloids · Cysts Submucosal Palatal Shrinkage · Head, Neck' Oral, and Sinus Surgery Tonsillectomy · Mastoidectomy Traditional Uvulopalatoplasty (RAUP) · Myringotomy with effective Hemorrhage Tumors Control Tissue in the Uvula/Soft Palate for the · Nasal Airway Obstruction by Reduction of Treatment of Snoring Hypertrophic Nasal Turbinates Uvulopalatopharyngoplasty (UPPP) · Nasopharyngeal / Laryngeal indications Parotidectomy including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking Neck Mass · Neck Dissection (Radical and Modified Neck Dissection) The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection, (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectomy and UPPP when used with the bipolar generator section of the G3 Workstation.

Source page: https://510kreport.com/device/K080844
Methodology: https://510kreport.com/methodology