Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ConMed Linvatec Australia Pty Ltd - Endoscopic electrosurgical electrode, bipolar, single-use
ARTG entry for
Medical Device Included Class IIb
ConMed Linvatec Australia Pty Ltd
PO Box 6064,FRENCHS FOREST DC, NSW, 2086
ARTG Start Date
Medical Device Class IIb
- 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.
Bovie Medical Corp
5115 Ulmerton Road
Clearwater, FL, 33760
United States Of America
1. Endoscopic electrosurgical electrode, bipolar, single-use
Single Device Product
61872 Endoscopic electrosurgical electrode, bipolar, single-use
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 07:03:32 AEDT
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