Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
K-Number: K173490 · 2018-02-22
ApplicantSTERIS Corporation
Decision Date2018-02-22
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2018-02-22 under approval number K173490. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)?
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by STERIS Corporation. The 510(k) number is K173490.
When was Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) approved by the FDA?
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) received FDA 510(k) clearance on 2018-02-22, under approval number K173490.
What company makes Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)?
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) is manufactured by STERIS Corporation.
What is the FDA product code for Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)?
The FDA product code for Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) is FLE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.