Summary for ARTG Entry:
CK Surgitech Pty Ltd - Endotherapy clip applier, single-use
ARTG entry for
Medical Device Included Class IIa
CK Surgitech Pty Ltd
16 / 227A Brisbane Road,BIGGERA WATERS, QLD, 4216
ARTG Start Date
Medical Device Class IIa
- 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.
Hangzhou AGS MedTech Co Ltd
320 Zhenhua Road
West Lake District, Hangzhou, 310030
1. Endotherapy clip applier, single-use
Single Device Product
32020 Endotherapy clip applier, single-use
An endotherapy device used in combination with a compatible flexible endoscope for the application of
haemostatic clips to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking,
haemostasis, tissue approximation, closure of luminal perforations, and/or for treating
mucosal/submucosal defects during an endoscopic procedure.
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.
Page 1 of
Produced at 10.11.2017 at 11:22:51 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