Australia TGA ARTG record

Shaver system, handpiece, powered

Australia TGA ARTG Registered Device · Olympus Australia Pty Ltd · Gyrus Acmi Inc · Class IIa · Started May 23, 2022

Good Name: Olympus Australia Pty Ltd - Shaver system, handpiece, powered

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 23, 2022
Effective Date: May 23, 2022

Sponsor

Name: Olympus Australia Pty Ltd

Manufacturer

Name: Gyrus Acmi Inc
Country: United States of America
Address: 9600 Louisiana Avenue North, Brooklyn Park, MN, 55445

Intended purpose

This system is intended for cutting, coagulation, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures.

About this record

Access comprehensive regulatory information for Shaver system, handpiece, powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Olympus Australia Pty Ltd, manufactured by Gyrus Acmi Inc in United States of America. The device registration started on May 23, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.