Search Results

The Indications for Use of the ViroSafe® 18 Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

Disposable Smoke Evacuation Filter

This document is a 510(k) clearance letter from the FDA for a medical device called the "Buffalo Filter ViroSafe 18 Filter." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details regarding a study.

Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a performance study outcome as typically described in scientific literature or a clinical trial report.

To answer your request, I would need a document that describes the design and results of a performance study for the Buffalo Filter ViroSafe 18 Filter.

Ask a specific question about this device