# K020067: Gyrus Ent Somnoplasty Generator

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Apr 4, 2002 after 85 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: 1 generation back to K000501 (2000). 1 ancestor in all.
77 later devices descend from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000501: Electrosurgical Generator, Model S1, Somnus Medical Technologies, Inc. (2000)

## Most influential descendants
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own
- 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

## Indications for use
The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K020067
Methodology: https://510kreport.com/methodology