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FDA 510(k)

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC

K-Number: K012573 · 2001-09-05

ApplicantGetinge/Castle, Inc.
Decision Date2001-09-05
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC is the device name listed in this FDA 510(k) record. The listed applicant is Getinge/Castle, Inc.. It received FDA 510(k) clearance on 2001-09-05 under 510(k) number K012573. 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 CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC?

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Getinge/Castle, Inc.. The 510(k) number is K012573.

When did CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC receive FDA 510(k) clearance?

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC received FDA 510(k) clearance on 2001-09-05, under 510(k) number K012573.

Who is the listed applicant for CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC?

The FDA 510(k) record lists Getinge/Castle, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC?

The FDA product code for CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC is FLE.

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Other records listing Getinge/Castle, Inc. 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.

K020205CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KITK020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZERK003441CASTLE MODEL 233HC STEAM STERILIZERK994314CASTLE SERIES 100HC STEAM STERILIZERSK993242CASTLE SURGICAL LIGHT, MODEL 3000K974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

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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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