Cleared Traditional

Celerity Chemical Indicator for enspire 3000 CLCSPS

K240032 · STERIS Corporation · General Hospital
Apr 2024
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K240032 is an FDA 510(k) clearance for the Celerity Chemical Indicator for enspire 3000 CLCSPS, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 17, 2024, 104 days after receiving the submission on January 4, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K240032 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2024
Decision Date April 17, 2024
Days to Decision 104 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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