# K970838: Somnus Model 30XX Disposable Tri-Needle Coagulating Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Jan 9, 1998 after 308 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 K963884 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963884: Somnus Disposable Multiple Electrode Coagulating Probe Model 350, Somnus Medical Technologies, Inc. (1996) Summary page 2.

## Indications for use
The Somnus Model 30xx Disposable Tri-Needle Coagulating Electrode is indicated for use in the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.

Source page: https://510kreport.com/device/K970838
Methodology: https://510kreport.com/methodology