Main information

  • Trade name:
  • Rigid endotherapy electrosurgical forceps, reusable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Rigid endotherapy electrosurgical forceps, reusable
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222630
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Karl Storz Endoscopy Australia Pty Ltd - Rigid endotherapy electrosurgical forceps, reusable

ARTG entry for

Medical Device Included Class IIb


Karl Storz Endoscopy Australia Pty Ltd

Postal Address

PO Box 50,LANE COVE, NSW, 1595


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




Karl Storz GmbH & Co KG

Mittelstrasse 8

TUTTLINGEN, Tuttlingen, D 78532



1. Rigid endotherapy electrosurgical forceps, reusable

Product Type

Single Device Product

Effective date



38709 Rigid endotherapy electrosurgical forceps, reusable

Intended purpose

A rigid endotherapy device, covered with a sheath of electrical insulation, designed to perform through a

compatible endoscope and to be connected to an electrosurgical diathermy or electrocautery generator to

provide electrical current to: 1) obtain tissue samples for histopathological examination; 2) allow for

coagulation so as to prevent bleeding; 3) destroy the residuum of the lesion being biopsied. It is typically

constructed as a long insulated metal instrument whose distal ends are equipped with scissors-like cups

with a cutting edge around their rim which are operated by scissors-like ring handles at the proximal end.

This is a reusable 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 09.11.2017 at 08:46:21 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