Endotherapy

Main information

  • Trade name:
  • Endotherapy electrosurgical diathermy system electrode, single-use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Endotherapy electrosurgical diathermy system electrode, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219617
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219617

Medical Industries Australia - Endotherapy electrosurgical diathermy system electrode, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medical Industries Australia

Postal Address

512 Creek Street,ALBURY, NSW, 2640

Australia

ARTG Start Date

25/01/2014

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

Bovie Medical Corp

5115 Ulmerton Road

Clearwater, FL, 33760

United States Of America

Products

1. Endotherapy electrosurgical diathermy system electrode, single-use

Product Type

Single Device Product

Effective date

25/01/2014

GMDN

38817 Endotherapy electrosurgical diathermy system electrode, single-use

Intended purpose

This is a non-dedicated active electrical conductor that is intended to be used for the vaporization,

ablation, coagulation and/or resection of soft tissues/structures typically during gynaecological, urological,

pulmonary, or gastrointestinal endotherapy surgical procedures. This is a single-use device.

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 07:02:41 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