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Andersen’s FDA 510k Clearances

Andersen Sterilizers FDA Cleared units

Andersen’s FDA 510(k) Clearances

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.

fda.gov

Andersen has worked closely with the US Food and Drug Administration (FDA) to gain 510(k) clearances for several of its sterilizers and accessories.

Why should you care if your sterilizer is FDA-cleared?

In the instance of EOGas 4 – 6 hour clearance, Andersen scientists proved that an 11-foot-long scope was effectively sterilized by culturing from not just one hard-to-reach place – but from seven. Repeatedly. On all the major scope brands. After the deadly CRE outbreaks of 2015, caused by scopes disinfected to then-current standards, the FDA set the clearance bar very high. We are very proud to say Andersen is the first and only company to have cleared the new hurdle.

Put simply, a clearance shows the government agency agrees with Andersen scientists – our sterilizers are safe and effective. Even if you do not work in a setting that demands an FDA-clearance, many of our customers like knowing our products have undergone rigorous testing that, then, passed a great deal of scrutiny.

EOGas 4

EOGas 4 – 6 hour

(product in development)

Anprolene AN75j front view

Anprolene AN75

EOGas 4

EOGas 4 – 3 hour