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FDA 510(k)

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

K-Number: K223717 · 2023-06-15

ApplicantSTERIS Corporation
Decision Date2023-06-15
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-06-15 under approval number K223717. 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 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by STERIS Corporation. The 510(k) number is K223717.

When was Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack approved by the FDA?

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack received FDA 510(k) clearance on 2023-06-15, under approval number K223717.

What company makes Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is manufactured by STERIS Corporation.

What is the FDA product code for Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

The FDA product code for Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is FRC.

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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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