Clamp

Main information

  • Trade name:
  • Clamp, surgical, uterine
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Clamp, surgical, uterine
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221828
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221828

Solo Gyn - Clamp, surgical, uterine

ARTG entry for

Medical Device Included Class 1

Sponsor

Solo Gyn

Postal Address

600 Stafford Road,STAFFORD, QLD, 4053

Australia

ARTG Start Date

31/03/2014

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Solo Gyn

600 Stafford Road

STAFFORD, QLD, 4053

Australia

Products

1. Clamp, surgical, uterine

Product Type

Single Device Product

Effective date

31/03/2014

GMDN

35804 Clamp, surgical, uterine

Intended purpose

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.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 09.11.2017 at 11:41:26 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

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