Endotherapy

Main information

  • Trade name:
  • Endotherapy device, active, single use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Endotherapy device, active, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217541
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217541

Olympus Australia Pty Ltd - Endotherapy device, active, single use

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

20/11/2013

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. Endotherapy device, active, single use

Product Type

Procedure Pack

Effective date

20/11/2013

GMDN

38817 Endotherapy electrosurgical diathermy system electrode, single-use

Intended purpose

An endotherapy device, the preloaded sphincterotomes and guidewires have been designed for

papillotomy using high-frequency current. The preloaded guidewire is used to guide and exchange

endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and

right and left hepatic ducts.

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 01:59:02 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