Summary for ARTG Entry:
Olympus Australia Pty Ltd - Endotherapy device, active, 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 Medical Systems Corporation
Tokyo, , 192-8507
1. Endotherapy device, active, single use
38817 Endotherapy electrosurgical diathermy system electrode, single-use
An endotherapy device, the preloaded sphincterotomes and guidewires have been designed for
papillotomy using high-frequency current. The preloaded guidewire is used to guide and exchange
endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and
right and left hepatic ducts.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:59:02 AEDT
This is not an ARTG Certificate document.
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