K160433 is an FDA 510(k) clearance for the V-PRO® 1 Plus and V-PRO® maX Low Temperature. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 6, 2016, 141 days after receiving the submission on February 16, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K160433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2016 |
| Decision Date | July 06, 2016 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |