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FDA 510(k)

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

K-Number: K213545 · 2023-02-02

ApplicantSteelco S.P.A.
Decision Date2023-02-02
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is the device name listed in this FDA 510(k) record. The listed applicant is Steelco S.P.A.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K213545. 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 Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Steelco S.P.A.. The 510(k) number is K213545.

When did Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 receive FDA 510(k) clearance?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 received FDA 510(k) clearance on 2023-02-02, under 510(k) number K213545.

Who is the listed applicant for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

The FDA 510(k) record lists Steelco S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

The FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is FLE.

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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