Summary for ARTG Entry:
Solo Gyn - Clamp, surgical, uterine
ARTG entry for
Medical Device Included Class 1
600 Stafford Road,STAFFORD, QLD, 4053
ARTG Start Date
Medical Device Class 1
- 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.
600 Stafford Road
STAFFORD, QLD, 4053
1. Clamp, surgical, uterine
Single Device Product
35804 Clamp, surgical, uterine
A surgical instrument, used during surgery on the uterus to grasp and/or manipulate and/or remove the
organ. It comprises external handle(s) and a variable number of customisable components; items intended
to be introduced into the body through the vagina for investigation, observation, excision, and/or biopsy
procedures. The vaginal delineator provides a protective, guide path for the dedicated clamp, as well as
facilitated support of the site during surgery. Thereafter, the vaginal delineator facilities the removal of the
uterus using the dedicated sliding, surgical clamp. Constructed from biocompatible polymers and/or
surgical grade stainless steel as a suitably long and wide instrument, the distal end is operated by a
straight or suitably angled element with ring-like or grasp handle(s) located at the proximal end of the
instrument. This is a reusable device.
No Specific Conditions included on Record
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