Cleared Special

VERIFY? Chemical Indicator for SYSTEM 1E? and SYSTEM 1? endo Liquid Chemical Sterilant Processing Systems

K233654 · Steris · General Hospital
Dec 2023
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K233654 is an FDA 510(k) clearance for the VERIFY? Chemical Indicator for SYSTEM 1E? and SYSTEM 1? endo Liquid Chemical Sterilant Processing Systems, 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 December 8, 2023, 24 days after receiving the submission on November 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K233654 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date December 08, 2023
Days to Decision 24 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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