K153689 is an FDA 510(k) clearance for the STERIZONE Sterilizer. This device is classified as a Two Or More Sterilant Sterilizer (Class II - Special Controls, product code PJJ).
Submitted by Tso3, Inc. (Quebec, CA). The FDA issued a Cleared decision on June 30, 2016, 190 days after receiving the submission on December 23, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 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..
| 510(k) Number | K153689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2015 |
| Decision Date | June 30, 2016 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PJJ — Two Or More Sterilant Sterilizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
| Definition | Intended For Use In Terminal Sterilization Of Cleaned, Rinsed, And Dried Metal And Non-metal Reusable Medical Devices In Health Care Facilities. |