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FDA 510(k)

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

K-Number: K020205 · 2002-06-24

ApplicantGetinge/Castle, Inc.
Decision Date2002-06-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT 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 2002-06-24 under 510(k) number K020205. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT?

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT is a medical device that received FDA 510(k) clearance on 2002-06-24. The listed applicant is Getinge/Castle, Inc.. The 510(k) number is K020205.

When did CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT receive FDA 510(k) clearance?

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT received FDA 510(k) clearance on 2002-06-24, under 510(k) number K020205.

Who is the listed applicant for CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT?

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 PERACETIC ACID BIOLOGICAL INDICATOR KIT?

The FDA product code for CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT is FRC.

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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.

K020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZERK012573CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HCK003441CASTLE MODEL 233HC STEAM STERILIZERK994314CASTLE SERIES 100HC STEAM STERILIZERSK993242CASTLE SURGICAL LIGHT, MODEL 3000K974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

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Related Devices (Code: FRC)

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.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

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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