Endoscopic electrosurgical electrode, bipolar, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
ConMed Linvatec Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
289400

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Public Summary

Summary for ARTG Entry:

289400

ConMed Linvatec Australia Pty Ltd - Endoscopic electrosurgical electrode, bipolar, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

ConMed Linvatec Australia Pty Ltd

Postal Address

PO Box 6064,FRENCHS FOREST DC, NSW, 2086

Australia

ARTG Start Date

26/05/2017

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. Endoscopic electrosurgical electrode, bipolar, single-use

Product Type

Single Device Product

Effective date

26/05/2017

GMDN

61872 Endoscopic electrosurgical electrode, bipolar, single-use

Intended purpose

A sterile, single-use, distal component of an electrosurgical system intended to be connected to a standard

electrosurgical generator with footswitch control and a standard return connector. The device operates in

bipolar mode without the need for an external grounding pad or return electrode, for cutting, coagulation,

ablation/vaporization of soft tissues during arthroscopic surgery and is activated only when immersed in a

conductive media such as a standard saline solution. It is available in aspirating and non-aspirating

versions. Aspirating versions allow the saline irrigant to be removed for the dissipation of heat and

improved vision, if required.

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 03.11.2017 at 07:03:32 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

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