Biopsy

Main information

  • Trade name:
  • Biopsy kit, ultrasonic aspiration
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biopsy kit, ultrasonic aspiration
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219532
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219532

William A Cook Australia Pty Ltd - Biopsy kit, ultrasonic aspiration

ARTG entry for

Medical Device Included Class IIa

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

23/01/2014

Product category

Medical Device Class IIa

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

Cook Ireland Ltd

O'Halloran Road National Technology Park

, Limerick,

Ireland

Products

1. Biopsy kit, ultrasonic aspiration

Product Type

Single Device Product

Effective date

23/01/2014

GMDN

10403 Biopsy kit, ultrasonic aspiration

Intended purpose

The Endobronchial HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle

biopsy (FNB) of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

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 07:16:37 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

There are no safety alerts related to this product.

4-5-2018

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Therapeutic Goods Administration - Australia