MED — Sterilant, Medical Devices Class II
FDA Device Classification
Classification Details
- Product Code
- MED
- Device Class
- Class II
- Regulation Number
- 880.6885
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K232914 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq | October 3, 2023 |
| K230582 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | March 28, 2023 |
| K222615 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | September 28, 2022 |
| K211607 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | September 7, 2021 |
| K210737 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | May 12, 2021 |
| K192929 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem | December 10, 2019 |
| K191343 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | September 5, 2019 |
| K190104 | steris corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem | March 22, 2019 |
| K182827 | steris corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | January 31, 2019 |
| K180342 | steris corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System | April 4, 2018 |
| K173256 | steris corporation | System 1 endo Liquid Chemical Sterilant Processing System | March 2, 2018 |
| K170956 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System | September 22, 2017 |
| K161683 | steris corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System | August 5, 2016 |
| K140703 | ciden technologies | OPA 30 SOLUTION | August 19, 2014 |
| K131078 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | July 5, 2013 |
| K120306 | minntech | RAPICIDE OPA-28 | September 27, 2012 |
| K113520 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | February 21, 2012 |
| K113015 | microchem laboratories | ALDAHOL V HIGH LEVEL DISINFECTANT | January 30, 2012 |
| K102462 | steris corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | September 21, 2010 |
| K101409 | steris corporation | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM | August 2, 2010 |