SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350

K963884 · Somnus Medical Technologies, Inc. · GEI · Dec 16, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963884
• Device Name: SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

Electrosurgical device; disposable tri-needle coagulating electrode. Used by qualified medical personnel for tissue coagulation. Device delivers electrosurgical energy to target tissue; facilitates coagulation. Clinical benefit: controlled tissue coagulation during surgical procedures.

Clinical Evidence

Bench testing only; performance validation testing conducted to demonstrate safety and effectiveness.

Technological Characteristics

Electrosurgical device; disposable tri-needle configuration. Operates via electrosurgical energy. Classified under 21 CFR 878.4400.

Indications for Use

Indicated for coagulation of tissue in patients requiring electrosurgical intervention; intended for use by qualified medical personnel.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

{0}

Somnus Medical Technologies, Inc.
510(k) #K963884, December 5, 1996

# 510(k) Summary of Safety and Effectiveness
Somnus Medical Technologies, Inc.™
Model 3000 Disposable Tri-Needle Coagulating Electrode
11-28-96

DEC 16 1996

K963884

## Intended Use:
The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

## Submitted By:
Somnus Medical Technologies, Inc.
995 Benecia Avenue
Sunnyvale, CA 94086
Tel: [phone]
Fax: [phone]

## Contact Person:
Eve A. Conner, Ph.D.
Vice President, Clinical and Regulatory Affairs
Tel: [phone]
Facsimile: 408-524-6264

## Name of Device:
Proprietary Name: Somnus Model 3000 Tri-Needle Coagulating Electrode
Common/Usual Name: Electrosurgical
Classification Name: Electrosurgical Device (per 21CFR 878.4400)

## Description:
The Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode is an electrosurgical device.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.

{1}

Somnus Medical Technologies, Inc.
510(k) #K963884, December 5, 1996

# Comparison to Predicate Devices:

The Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
000052