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FDA 510(k)

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

K-Number: K183300 · 2019-01-03

ApplicantSteris Corporations
Decision Date2019-01-03
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183300. 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 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Steris Corporations. The 510(k) number is K183300.

When did VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack receive FDA 510(k) clearance?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183300.

Who is the listed applicant for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

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

What is the FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is FRC.

Other records listing Steris Corporations 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.

K203630BioGuard Air/Water and Suction ValvesK190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemK183295Celerity HP Chemical Indicator (CI)K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker TagK180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemK172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

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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)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS 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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