Cleared Special

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

K222440 · Steris · General Hospital
Sep 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K222440 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 9, 2022, 28 days after receiving the submission on August 12, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K222440 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2022
Decision Date September 09, 2022
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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