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FDA 510(k)

GSS610N21 Series Steam Sterilizer

K-Number: K214120 · 2022-05-18

ApplicantMaquet GmbH
Decision Date2022-05-18
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GSS610N21 Series Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Maquet GmbH. It received FDA 510(k) clearance on 2022-05-18 under 510(k) number K214120. 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 GSS610N21 Series Steam Sterilizer?

GSS610N21 Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Maquet GmbH. The 510(k) number is K214120.

When did GSS610N21 Series Steam Sterilizer receive FDA 510(k) clearance?

GSS610N21 Series Steam Sterilizer received FDA 510(k) clearance on 2022-05-18, under 510(k) number K214120.

Who is the listed applicant for GSS610N21 Series Steam Sterilizer?

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

What is the FDA product code for GSS610N21 Series Steam Sterilizer?

The FDA product code for GSS610N21 Series Steam Sterilizer is FLE.

Other records listing Maquet GmbH as applicant

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.

K201927Getinge GSS610N Series Steam SterilizerK172159Getinge GSS67N Series Steam Sterilizer

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

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

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