Andersen’s FDA 510k Clearances
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 – 6 hour
(product in development)
- EOGas 4 – 6 hour Sterilizer
(Spanish, French) - Endo-SteriTest Rapid Readout (self-contained biological indicator with 4-hour incubation)
- Endo-SteriTest (self-contained biological indicator)
- AN1036 Dosimeter (Single-use color change chemical indicator to verify adequate cumulative EO exposure in a 3- or 6-hour EOGas 4 cycle)
- Sterisheet® Sterilization Wrap (After completion of the EOGas 4 sterilization process, sterility is maintained for 6 months in Sterisheet sterilization wraps.)
- Tyvek® Sterilization Pouches with Chevron Seal (After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.)
Anprolene AN75
- Anprolene AN75 Sterilizers
(Spanish, French) - Anprolene Steritest (self-contained biological indicator)
- AN87 Dosimeter (Single-use color change chemical indicator to verify adequate cumulative EO exposure in a 12-hour Anprolene AN75 cycle)
- AN85 Exposure Indicator (Single-use indicators of processed vs. unprocessed packaged medical devices, through a visible color change from yellow-green to blue.)
- Sterisheet® Sterilization Wrap (Sterility was maintained for at least 3 months after processing in an Anprolene sterilization cycle.)
- Tyvek® Sterilization Pouches with Chevron Seal (Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.)
EOGas 4 – 3 hour
- EOGas 4 – 3 hour Sterilizer
(Spanish, French) - EOGas 4 Steritest (self-contained biological indicator)
- AN1087 Dosimeter (Single-use color change chemical indicator to verify adequate cumulative EO exposure in a 3-hour EOGas 4 cycle)
- AN85 Exposure Indicator (Single-use indicators of processed vs. unprocessed packaged medical devices, through a visible color change from yellow-green to blue.)
- Sterisheet® Sterilization Wrap (Sterility was maintained for at least 3 months after processing in an EOGas 4 sterilizer.)
- Tyvek® Sterilization Pouches with Chevron Seal (After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months.)