Summary for ARTG Entry:
CK Surgitech Pty Ltd - Endotherapy snare, electrosurgical, single use
ARTG entry for
Medical Device Included Class IIb
CK Surgitech Pty Ltd
16 / 227A Brisbane Road,BIGGERA WATERS, QLD, 4216
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.
Micro-Tech Nanjing Co Ltd
No 10 Gaoke Third Road Nanjing National
Industrial Development Zone, Jiangsu, 210061
1. Endotherapy snare, electrosurgical, single use
Single Device Product
38827 Endotherapy snare, electrosurgical, single use
A device intended to be used to ligate, cauterize, and cut tissue and polyps by using a high frequency
current during endotherapy. It consists of an insulated insertion sheath, a snare loop attached to the distal
end of the sheath, an operating wire connected with both the loop and the handle which controls the
operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit.
It is disposable.
No Specific Conditions included on Record
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