K182568 is an FDA 510(k) clearance for the V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System. 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 January 3, 2019, 107 days after receiving the submission on September 18, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K182568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2018 |
| Decision Date | January 03, 2019 |
| Days to Decision | 107 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 |