PJJClass II
Two Or More Sterilant Sterilizer
General Hospital · 21 CFR 880.6860
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances6All time
Recent MDR events
6 adverse event reports on file
- STERIZONE VP4 STERILIZERJul 21, 2017InjuryTso3 Inc.3011762828-2017-00002
- STERIZONE VP4 STERILIZERJul 21, 2017InjuryTso3 Inc.3004148947-2017-00002
- STERIZONE VP4 STERILIZERJul 21, 2017InjuryTso3 Inc.3011762828-2017-00003
- STERIZONE VP4 STERILIZERJul 21, 2017InjuryTso3 Inc.3004148947-2017-00003
- STERIZONE VP4 STERILIZERJul 20, 2017InjuryTso3 Inc.3004148947-2017-00001
- STERIZONE VP4 STERILIZERJul 20, 2017InjuryTso3 Inc.3011762828-2017-00001
Event type breakdown
Injury6
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
6 clearances for this product code
- Tso3, Inc.Jul 19, 2019
K190260 · STERIZONE(R) VP4 Sterilizer
- Tso3, Inc.May 9, 2018
K172191 · STERIZONE VP4 Sterilizer
- Tso3, Inc.Mar 13, 2018
K173694 · STERIZONE VP4 Sterilizer
- Tso3, Inc.Jun 30, 2016
K153689 · STERIZONE Sterilizer
- Ts03, Inc.Mar 24, 2016
K153392 · STERIZONE VP4 Sterilizer
- Tso3, Inc.Dec 17, 2014
K141163 · STERIZONE STERILIZER