Cleared Special

CELERITY HP Indicator Tape (PCC077)

K242189 · Steris · General Hospital
Aug 2024
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K242189 is an FDA 510(k) clearance for the CELERITY HP Indicator Tape (PCC077), 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 20, 2024, 26 days after receiving the submission on July 25, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K242189 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2024
Decision Date August 20, 2024
Days to Decision 26 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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