Whiteley Corporation Announces FDA Clearance for ENDOX® – Advancing Endoscope Reprocessing in the United States

Australian-developed infection prevention technology strengthens Whiteley’s international medical device reprocessing portfolio.

Whiteley Corporation, an Australian manufacturer of infection prevention and medical device reprocessing technologies, is pleased to announce that its ENDOX® endoscope disinfectant and sterilant system has received US FDA approval on Friday 16th of October. This marks an important milestone in the company’s international growth strategy and commitment to advancing healthcare infection prevention.

ENDOX® is a peracetic acid-based high-level disinfectant and sterilant. The system is designed for use in compatible automated endoscope reprocessors (AERs) to support the reprocessing of endoscopes and related accessories.

The FDA approval is an important next step in expanding access to Whiteley’s Australian-developed reprocessing technology in the United States, one of the world’s largest healthcare markets.

The regulatory clearance of ENDOX® in the United States of America is the second major breakthrough and comes in addition to the existing approval for ENDOX® in Canada.

Supporting healthcare infection prevention

Effective endoscope reprocessing is essential to healthcare-associated infection prevention. Healthcare facilities require reliable, validated reprocessing systems that support the safe reuse of compatible medical devices in accordance with applicable instructions for use and regulatory requirements.

ENDOX® has been developed to provide high-level disinfection and sterilisation capabilities within compatible automated endoscope reprocessing systems, with validated processing parameters intended to support efficient clinical workflows.

A milestone in Whiteley’s international growth

“Achieving this FDA approval for ENDOX® is a tremendous accomplishment for the Whiteley business, and reflects our ongoing commitment to innovation, scientific rigour and healthcare infection prevention,” said Dr Greg Whiteley.

“ENDOX® represents the application of Australian manufacturing capability and technical expertise to the evolving needs of medical device reprocessing. We look forward to building on this achievement as we expand our international presence and work with healthcare partners to support improved reprocessing practices.”

Australian innovation with global ambitions

Whiteley Corporation has a long history in infection prevention, medical device reprocessing and professional hygiene. The company develops and manufactures specialised products for healthcare and other professional environments, with a focus on product performance, quality and practical solutions for healthcare providers.

The FDA approval of ENDOX® reinforces Whiteley’s ambition to extend its reprocessing technologies into additional international markets and strengthen its position in the global infection prevention sector.

About Whiteley Corporation

Whiteley Corporation is an Australian manufacturer focused on Liquid Medical Devices for infection prevention, medical device reprocessing, medical hand hygiene and professional hygiene products. Established in 1933, the company develops specialised solutions for healthcare facilities and professional environments, combining manufacturing expertise with a commitment to product quality and innovation.

For more information, visit www.whiteley.com.au.

Media enquiries:
Kasey Halam – Whiteley Marketing
Kasey.Halam@Whiteley.com.au