# K970809: Bendable Tissue Coagulating Electrode with Bending Tool

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Jun 18, 1997 after 105 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 K961133 (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)
- K961133: Somnus Medical Tech. Malleable Coagulating Electrode, Somnus Medical Technologies, Inc. (1996) Summary page 2.

## Indications for use
The Somnus Model 1000 - Needle Sleeve Bending Tool is intended to change the angle of deployment of the needle for the Model 1000 - Single Needle Coagulating Electrodes by creating a radial bend in the needle sleeve. 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/K970809
Methodology: https://510kreport.com/methodology