Cleared Special

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

K233187 · Steris · General Hospital
Oct 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K233187 is an FDA 510(k) clearance for the Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on October 27, 2023, 29 days after receiving the submission on September 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K233187 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date October 27, 2023
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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