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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 the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2021-10-28 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K212424.

When did AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers receive FDA 510(k) clearance?

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

Who is the listed applicant for AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing STERIS Corporation as applicant

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K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

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Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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