FDA News

PuriCore Receives FDA Approval for Endoscope Disinfectant System

(April 5, 2007)-- PuriCore announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA), allowing it to market its proprietary Sterilox Endoscopy High-Level Disinfectant System as a medical device in the U.S. The Sterilox System is designed to produce a highly effective and safe high-level disinfectant solution that is indicated for use in reprocessing and disinfecting heat-sensitive medical instruments, including endoscopes, between patient procedures.

The Sterilox Endoscopy System is based on existing patented and patent-pending PuriCore technology and products that are currently marketed in Europe (primarily in the U.K.). It produces principally hypochlorous acid, the natural antimicrobial produced by the human body to fight pathogens, from the electrolysis of a saline solution. Sterilox Solutions are completely non-toxic and are of no risk to patients, healthcare professionals, or the environment.

"This is a big step in bringing Sterilox to the U.S. endoscopy market, which is the largest in the world," said Greg Bosch, PuriCore CEO. "We are now developing our commercialization plan and, upon the completion of post-clearance testing, we anticipate installing our first U.S. beta sites for Sterilox Endoscopy Systems by year-end."

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