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STERIS Corporation

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STERIS Corporation’s 2023 510(k) summary in FDA record K223476 describes the V-PRO maX 2 Low Temperature Sterilization System.

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STERIS Corporation’s 2023 510(k) summary in FDA record K223476 describes the V-PRO maX 2 Low Temperature Sterilization System. The submission describes a vapor-phase hydrogen peroxide system intended to sterilize properly prepared medical devices in healthcare facilities.

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  1. 1
    Government recordOfficial exact-entity information

    U.S. Food and Drug Administration · Supports Organization · description

    “STERIS Corporation 5960 Heisley Road Mentor, OH 44060 V-PRO maX 2 Low Temperature Sterilization System Vapor Phase Hydrogen Peroxide Sterilizer The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. Submission Date: August 1, 2023 U.S. Food & Drug Administration August 7, 2023”

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