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FDA 510(k)

Amsco Evolution Medium Steam Sterilizer

K-Number: K173485 · 2018-02-22

Decision Date2018-02-22
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Amsco Evolution Medium Steam Sterilizer is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2018-02-22 under approval number K173485. 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?

Amsco Evolution Medium Steam Sterilizer 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 K173485.

When was Amsco Evolution Medium Steam Sterilizer approved by the FDA?

Amsco Evolution Medium Steam Sterilizer received FDA 510(k) clearance on 2018-02-22, under approval number K173485.

What company makes Amsco Evolution Medium Steam Sterilizer?

Amsco Evolution Medium Steam Sterilizer is manufactured by STERIS Corporation.

What is the FDA product code for Amsco Evolution Medium Steam Sterilizer?

The FDA product code for Amsco Evolution Medium Steam Sterilizer is FLE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.