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FDA 510(k)

CELERITY 20 Steam Biological Indicator

K-Number: K181686 · 2018-07-24

ApplicantSTERIS Corporation
Decision Date2018-07-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELERITY 20 Steam Biological Indicator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2018-07-24 under approval number K181686. 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 20 Steam Biological Indicator?

CELERITY 20 Steam Biological Indicator is a medical device that received FDA 510(k) clearance on 2018-07-24. It is manufactured by STERIS Corporation. The 510(k) number is K181686.

When was CELERITY 20 Steam Biological Indicator approved by the FDA?

CELERITY 20 Steam Biological Indicator received FDA 510(k) clearance on 2018-07-24, under approval number K181686.

What company makes CELERITY 20 Steam Biological Indicator?

CELERITY 20 Steam Biological Indicator is manufactured by STERIS Corporation.

What is the FDA product code for CELERITY 20 Steam Biological Indicator?

The FDA product code for CELERITY 20 Steam Biological Indicator 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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