Electrosurgical

Main information

  • Trade name:
  • Electrosurgical diathermy system conducting unit, hand-controlled, evacuation, single-use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrosurgical diathermy system conducting unit, hand-controlled, evacuation, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221499
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221499

Medical & Optical Instruments Australia Pty Ltd - Electrosurgical diathermy system conducting unit,

hand-controlled, evacuation, single-use

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

20/03/2014

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

Hangzhou MedStar Technology Co Ltd

Fengdou Village Pingyao Town

Yuhang District, Hangzhou, 311115

China

Products

1. Electrosurgical diathermy system conducting unit, hand-controlled, evacuation, single-use

Product Type

Single Device Product

Effective date

20/03/2014

GMDN

47131 Electrosurgical diathermy system conducting unit, hand-controlled, evacuation, single-use

Intended purpose

An electrical conductor comprised of an electrode handpiece with cables and an active electrode, and an

integrated smoke and/or liquid evacuation system. This provides an electrical connection between the

electrosurgical diathermy generator and a patient. The energy emitted from the device is used to cut and

coagulate tissue at the surgical site while it simultaneously captures the resultant plume and /or liquid, and

conducts it to a suction system/smoke evacuator. Single use.

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 12:51:37 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