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FDA 510(k)

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

K-Number: K233187 · 2023-10-27

ApplicantSteris
Decision Date2023-10-27
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2023-10-27 under approval number K233187. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)?

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Steris. The 510(k) number is K233187.

When was Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) approved by the FDA?

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) received FDA 510(k) clearance on 2023-10-27, under approval number K233187.

What company makes Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)?

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) is manufactured by Steris.

What is the FDA product code for Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)?

The FDA product code for Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) is JOJ.

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Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

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Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, Inc.

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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