Electrode

Main information

  • Trade name:
  • Electrode, electrosurgical, active, hand-controlled, single use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrode, electrosurgical, active, hand-controlled, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219573
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219573

Medical & Optical Instruments Australia Pty Ltd - Electrode, electrosurgical, active, hand-controlled, single

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medical & Optical Instruments Australia Pty Ltd

Postal Address

PO Box 850,ARTARMON, NSW, 1570

Australia

ARTG Start Date

24/01/2014

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

Kirwan Surgical Products Inc

180 Enterprise Drive

Marshfield, MA, 02050

United States Of America

Products

1. Electrode, electrosurgical, active, hand-controlled, single use

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

35044 Electrode, electrosurgical, active, hand-controlled, single use

Intended purpose

A single use device, generally in the form of a pen or pencil, is used as an electrical conductor between an

electrosurgical generator and a patient. The electrical power switch for this device is part of the electrode

and allows the surgeon to hand control the unit

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 07:07:48 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