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FDA 510(k)

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers

K-Number: K212424 · 2021-10-28

ApplicantSTERIS Corporation
Decision Date2021-10-28
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2021-10-28 under approval number K212424. 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 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers?

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by STERIS Corporation. The 510(k) number is K212424.

When was AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers approved by the FDA?

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers received FDA 510(k) clearance on 2021-10-28, under approval number K212424.

What company makes AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers?

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers is manufactured by STERIS Corporation.

What is the FDA product code for AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers?

The FDA product code for AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers is FLE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41123878 Medical devices in Europe, all but drugs: time to radically change their regulation? Internal and emergency medicine (2026)

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Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

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.

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