Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860) → PJJ — Two Or More Sterilant Sterilizer

# PJJ · Two Or More Sterilant Sterilizer

_General Hospital · 21 CFR 880.6860 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ

## Overview

- **Product Code:** PJJ
- **Device Name:** Two Or More Sterilant Sterilizer
- **Regulation:** [21 CFR 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190260](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K190260.md) | STERIZONE(R) VP4 Sterilizer | Tso3, Inc. | Jul 19, 2019 | SESE |
| [K172191](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K172191.md) | STERIZONE VP4 Sterilizer | Tso3, Inc. | May 9, 2018 | SESE |
| [K173694](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K173694.md) | STERIZONE VP4 Sterilizer | Tso3, Inc. | Mar 13, 2018 | SESE |
| [K153689](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K153689.md) | STERIZONE Sterilizer | Tso3, Inc. | Jun 30, 2016 | SESE |
| [K153392](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K153392.md) | STERIZONE  VP4  Sterilizer | Ts03, Inc. | Mar 24, 2016 | SESE |
| [K141163](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ/K141163.md) | STERIZONE STERILIZER | Tso3, Inc. | Dec 17, 2014 | SESE |

## Top Applicants

- Tso3, Inc. — 5 clearances
- Ts03, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PJJ)

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