PJJ · Two Or More Sterilant Sterilizer
General Hospital · 21 CFR 880.6860 · Class 2
Overview
| Product Code | PJJ |
|---|---|
| Device Name | Two Or More Sterilant Sterilizer |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | STERIZONE(R) VP4 Sterilizer | Tso3, Inc. | Jul 19, 2019 | SESE |
| K172191 | STERIZONE VP4 Sterilizer | Tso3, Inc. | May 9, 2018 | SESE |
| K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | Mar 13, 2018 | SESE |
| K153689 | STERIZONE Sterilizer | Tso3, Inc. | Jun 30, 2016 | SESE |
| K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | Mar 24, 2016 | SESE |
| K141163 | STERIZONE STERILIZER | Tso3, Inc. | Dec 17, 2014 | SESE |
Top Applicants
- Tso3, Inc. — 5 clearances
- Ts03, Inc. — 1 clearance
