Summary for ARTG Entry:
Olympus Australia Pty Ltd - Endotherapy electrosurgical diathermy system electrode, single-use
ARTG entry for
Medical Device Included Class IIb
Olympus Australia Pty Ltd
PO Box 985,MOUNT WAVERLEY, VIC, 3149
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.
Olympus Winter & Ibe GmbH
, Hamburg, 22045
1. Endotherapy electrosurgical diathermy system electrode, single-use
Single Device Product
38817 Endotherapy electrosurgical diathermy system electrode, single-use
A non-dedicated active electrical conductor designed for the vaporization, ablation, coagulation and/or
resection of soft tissues/structures typically during gynaecological, urological or surgical procedures. It is a
long thin device that is inserted through the working channel of a compatible endoscope (e.g., a
resectoscope, cystoscope, hysteroscope) and is connected to a radio-frequency (RF) generator which
supplies the energy that is transmitted to the distal end of the device. It can have a wide variety of tip
configurations and sizes. This is a single-use device.
No Specific Conditions included on Record
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