Cleared Special

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

K222093 · Steris · General Hospital
Sep 2022
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K222093 is an FDA 510(k) clearance for the V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 9, 2022, 56 days after receiving the submission on July 15, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K222093 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2022
Decision Date September 09, 2022
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MLR — Sterilizer, Chemical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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