HAW RIVER, N.C.--(BUSINESS WIRE)--Aug 8, 2023--
Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program.
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Andersen Sterilizers has won 18 FDA clearances on its tabletop sterilizers and accessories since 2015. The most recent 510(k) clearance includes terminal sterilization of duodenoscopes up to 11.6 feet long and with channels down to 1.2 mm diameter. (Photo: Business Wire)
As a result, 510(k) holders of devices labeled as sterile that wish to begin using Andersen Sterilizers' EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized class I or class II devices may reference the Andersen Sterilizers master file rather than submitting a new 510(k) for the sterilization change.
"We were awarded the FDA Innovation Challenge 2 for reducing ethylene oxide emissions with our proprietary technology three years ago," said Ted May, Andersen Products CEO. "The FDA asked how they could help us as we further this mutual goal. We mentioned the hurdle (or perceived hurdle) for potential new customers worried that they will need to submit a new 510(k) if they switch from a traditional sterilization system to either Andersen Sterilizer's EOGas 4 or EOGas 3 in-house systems or to Andersen Scientific's contract sterilization services. This master file makes it official, switching to Andersen just got even easier."
Andersen Sterilizers sterilization systems use a proprietary flexible chamber, which requires less EO than established EO systems, supporting the FDA’s goal of minimizing the use of EO. Andersen Sterilizers designs and manufactures innovative tabletop and refrigerator-sized EO gas sterilizers for the manufacturing, research, medical and veterinary markets. Andersen Scientific specializes in small- to medium-lot sterilization, custom cycles and fast turnaround.
Andersen Sterilizers designs and manufactures gas sterilizers for the veterinary, medical, research and manufacturing markets. American made, family-owned and trusted for over 60 years. Andersen Sterilizers headquarters is in Haw River, North Carolina, operates a UK office in Essex and partners with a select group of distributors around the world.
Andersen Scientific is so much more than a commercial sterilization facility focused on small to medium volume clients. The company is committed to exacting standards of quality and customer service, while serving customers as the “go-to” professionals knowledgeable in all matters relating to ethylene oxide sterilization. Andersen Scientific is quite possibly the most environmentally friendly ethylene oxide contract sterilization facility in the world.
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Angela Labrecque – Digital Marketing Specialist, 1.800.523.1276,angela.labrecque@sterility.com
KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA
INDUSTRY KEYWORD: OTHER MANUFACTURING RESEARCH MEDICAL DEVICES HOSPITALS MANUFACTURING BIOTECHNOLOGY HEALTH GENERAL HEALTH SCIENCE
SOURCE: Andersen Sterilizers
Copyright Business Wire 2023.
PUB: 08/08/2023 08:48 AM/DISC: 08/08/2023 08:46 AM
http://www.businesswire.com/news/home/20230808827853/en
