K153392 is an FDA 510(k) clearance for the STERIZONE VP4 Sterilizer. This device is classified as a Two Or More Sterilant Sterilizer (Class II - Special Controls, product code PJJ).
Submitted by Ts03, Inc. (Quebec, CA). The FDA issued a Cleared decision on March 24, 2016, 121 days after receiving the submission on November 24, 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 | K153392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2015 |
| Decision Date | March 24, 2016 |
| Days to Decision | 121 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. |