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Disposable battery-powered surgical/orthopaedic lavage system

Access comprehensive regulatory information for Disposable battery-powered surgical/orthopaedic lavage system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Evolution Surgical Pty Ltd, manufactured by Richard Wolf GmbH in Germany. The device registration started on May 26, 2023.

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Disposable battery-powered surgical/orthopaedic lavage system
Australia TGA ARTG Registered Device
Good Name: Evolution Surgical Pty Ltd - Disposable battery-powered surgical/orthopaedic lavage system
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Intended Purpose

The Fluid Control Arthro device is an irrigation and suction pump designed for use in endoscopic spinal surgery and an irrigation pump for diagnostic and /or surgical arthroscopic procedures. For endoscopic spinal surgery, the irrigation pump is used to produce a continuous flow of the irrigation fluid through the irrigation channel of an endoscope for optimal visualisation of the surgical field, while the suction pump is used to create a vacuum in a vacuum container. The tubes and the cannulated suction instruments connected to the container serve to extract fluids, secretions, and particles from the surgical field. For arthroscopic surgery, the irrigation pump serves to distend and irrigate joints in the knee, shoulder, hip, elbow, as well the wrist and ankle joint.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 26, 2023
Effective Date
May 26, 2023
Manufacturer
Country
Germany
Address
Pforzheimer strasse 32, Knittlingen, 75438