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EOGas 4 Duodenoscope FDA 510(k) Clearance Image
FDA Cleared
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VENDOR SPOTLIGHT PODCAST

Superbugs Be Gone:
FDA’s First 510(k) Clearance for Terminal Sterilization of
Duodenoscopes

 

Andersen Sterilizers News  | JANUARY 15, 2021

Haw River, NC—Picture this: you turn on the news and the announcer leads with breaking news “Infectious outbreak linked to hospital and clinic endoscopes.” Let the media storm and regulatory survey frenzy begin!

As Sterile Processing professionals, this is our industry’s worst nightmare and on a recent Vendor Spotlight, Beyond Clean talks with Ted May, Andersen Sterilizers CEO, and Dr. Larry Muscarella of LFM Healthcare Solutions LLC about a one-of-a-kind sterilization technology proven to sterilize the toughest endoscopes on the market.

"Our FDA clearance is the first terminal sterilization clearance for duodenoscopes. We’re offering a dry process that allows you to store scopes for up to 6 months and it’s offering a 10-6 sterility assurance level. This is true sterilization unlike the other options on the market. I think this is going to be a real game changer for healthcare facilities that want to sterilize these very critical instruments."

Ted May

Ted May introduces the EOGas 4 ― the first sterilization system to receive FDA 510(k) clearance for terminal sterilization of duodenoscopes and colonoscopes.

Dr. Muscarella offers his device reprocessing expertise to support the use of ethylene oxide (EO) for endoscope sterilization.

Tune in now to discover how this high-efficiency EO sterilization system is ensuring the highest level of sterility.

EOGas 4 FDA 510(k) Resources
EOGas 4 510(k) - K192978
Endo-SteriTest BI 510(k) - K5192980

(Self-contained biological indicator)

FDA Letter
Indications for Use
Summary

Andersen’s new version of the EOGas 4, featuring a 6-hour cycle, has been put into production immediately upon receiving the clearance.

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