# K993112: Xomed Ent RF System

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Dec 9, 1999 after 83 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 K980177 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990146: Surgitron, Ellman Intl., Inc. (1999) Summary page 2.
- K980177: Sugitron Model: Iec, Ellman Intl., Inc. (1998) Summary page 2.

## Indications for use
The Xomed ENT RF system is for use by qualified surgeons familiar with radio-frequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation. Indications in general surgery are for cutting, removal, and coagulation of tissues. Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.

Source page: https://510kreport.com/device/K993112
Methodology: https://510kreport.com/methodology