Electrosurgical

Main information

  • Trade name:
  • Electrosurgical unit, cautery, line powered
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrosurgical unit, cautery, line powered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218541
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218541

Olympus Australia Pty Ltd - Electrosurgical unit, cautery, line powered

ARTG entry for

Medical Device Included Class IIb

Sponsor

Olympus Australia Pty Ltd

Postal Address

PO Box 985,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

13/12/2013

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Olympus Medical Systems Corporation

2951 Ishikawa-cho

Hachioji- shi

Tokyo, , 192-8507

Japan

Products

1. Electrosurgical unit, cautery, line powered

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

35030 Electrosurgical unit, cautery, line powered

Intended purpose

A heat-generating device designed to heat the tip of electrical probes or blades for coagulation of tissue.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:08:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information