Cleared Traditional

Celerity? HP Chemical Indicator; Celerity? HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape

K231488 · Steris · General Hospital
Aug 2023
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K231488 is an FDA 510(k) clearance for the Celerity? HP Chemical Indicator; Celerity? HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape, 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 August 7, 2023, 76 days after receiving the submission on May 23, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K231488 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2023
Decision Date August 07, 2023
Days to Decision 76 days
Submission Type Traditional
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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