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Sterizone Sterilizer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141163

by Tso3, Inc.

Identifiers

510(k) Number
K141163 FDA 510(k)
FDA Product Code
PJJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6860 FDA 510(k)
Regulation Number
880.6860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sterizone VP4 Sterilizer is a two or more sterilant sterilizer intended for the terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices. It utilizes a process involving the injection of vaporized hydrogen peroxide followed by ozone to achieve sterilization.

This device is designed for use in health care facilities to process low temperature sterilizable equipment, including complex multi-channel flexible endoscopes. It has received FDA 510(k) clearance under regulation number 880.6860.

Frequently asked questions

What is the Sterizone VP4 Sterilizer used for?

The Sterizone VP4 is intended for the terminal sterilization of cleaned, rinsed, and dried reusable medical devices. It is specifically designed for health care facilities to process low-temperature sterilizable equipment, including complex multi-channel flexible endoscopes.

How does the Sterizone VP4 achieve sterilization?

This device utilizes a dual-sterilant process. It works by injecting vaporized hydrogen peroxide into the chamber, which is then followed by the injection of ozone to complete the sterilization cycle.

What is the regulatory status of the Sterizone Sterilizer?

The Sterizone Sterilizer has received FDA 510(k) clearance under regulation number 880.6860. It is classified as a Class 2 medical device under the product code PJJ, indicating it has been found substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF TSO3 Inc ℅ Cynthia Pritcha - Food and Drug Administration, K190260 - STERIZONE (R) VP4 Sterilizer - General Hospital, Sterizone VP4 - Stryker, K172191 FDA 510(k) - STERIZONE VP4 Sterilizer | Tso3, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tso3, Inc.

Sources (1)

  • FDA 510(k) K141163 24 fields · synced Sep 21, 2026